Job Openings Moniteur centralisé / Centralized Monitor About the job Moniteur centralisé / Centralized Monitor Job Title: Moniteur centralisé / Centralized Monitor Job Location: Kirkland, Quebec, Canada Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: ** Pour être éligible à ce poste, vous devez résider dans le même pays/la même région commerciale où se trouve l'emploi **Location: Canada, TélétravailAperçu du posteGérer l’exécution des études cliniques attribuées, de leur démarrage jusqu’à leur clôture. Veiller à ce que la gestion des études cliniques et les livrables du projet soient réalisés dans les délais prescrits et conformément aux procédures opérationnelles normalisées (PON), aux politiques et aux pratiques établies. Fournir du soutien et de l’assistance liés aux projets dans le cadre de plusieurs projets, sites et équipes, et examiner les données cliniques structurées avec accès aux dossiers médicaux. S’assurer que le travail est effectué conformément aux PON, aux politiques, aux bonnes pratiques cliniques (BPC) et aux exigences réglementaires applicables. Veiller au respect du protocole, à l’exhaustivité globale et à l’état de préparation des renseignements fournis sur les patients pour le niveau suivant de révision, tout en respectant les indicateurs de performance et les échéanciers.Faciliter un examen efficace des rapports de visites de site et assurer l’application uniforme des normes de qualité afin d’atteindre ou de dépasser les standards établis. Veiller à la sécurité des participants, à l’intégrité des données, à l’escalade des problèmes ainsi qu’à la transmission rapide et appropriée de la rétroaction, conformément aux PON d’IQVIA, aux lignes directrices de la Conférence internationale sur l’harmonisation – Bonnes pratiques cliniques (ICH-GCP), aux exigences des protocoles et aux exigences réglementaires.Élaborer et utiliser des plans de gestion d’étude, des outils et modèles de surveillance fondée sur les risques ainsi que d’autres plans propres aux études afin d’évaluer la qualité et l’intégrité de celles-ci. Soutenir l’équipe de gestion de projet dans l’élaboration de stratégies de surveillance, y compris la définition de déclencheurs et de seuils de surveillance. Assurer le suivi opérationnel des projets attribués et effectuer les analyses de tendances relatives aux indicateurs des études/sites (analyse des tendances des aspects cliniques de l’essai, communication des tendances, élaboration et suivi des plans d’action, examen, triage et gestion des alertes d’études cliniques, surveillance de la conformité au Plan des opérations cliniques [COP], etc.).Fonctions essentiellesGérer les sites attribués et effectuer de façon autonome les revues des données au niveau des participants (Subject Level Data Review); au besoin, assumer les deux responsabilités dans un rôle double.Réaliser les visites de surveillance à distance pour les sites assignés.Effectuer les revues des données au niveau des participants nécessitant une investigation supplémentaire auprès du site clinique afin de déterminer l’exactitude globale (critères d’inclusion et d’exclusion, produit expérimental [IP], événements indésirables [EI], résultats de laboratoire, fin de traitement [EOT], fin de l’étude [EOS], critères d’évaluation, événements indésirables graves [EIG], etc.). Examiner toute autre information pertinente afin d’évaluer l’état de préparation du dossier du participant pour le niveau suivant de révision.Réaliser des analyses propres aux études conformément aux plans applicables. Contribuer à l’élaboration de nouvelles propositions analytiques selon les besoins des clients et être en mesure de rédiger des interprétations analytiques apportant une valeur ajoutée.Assurer le suivi opérationnel des sites et études assignés et effectuer les analyses de tendances des indicateurs des études/sites (analyse des tendances des aspects cliniques de l’essai, communication des tendances, élaboration de plans d’action, gestion des alertes cliniques, surveillance de la conformité au COP, etc.).Fournir, sous supervision, des contributions aux équipes d’études cliniques, aux décideurs clés et aux membres de l’équipe interne afin de soutenir l’amélioration continue des processus, l’escalade des enjeux et les prévisions de charge de travail.Identifier la valeur ajoutée de la revue centralisée et de la surveillance à distance dans les études et fournir des recommandations aux parties prenantes concernées.Soutenir les responsables CMS dans la supervision des livrables cliniques des projets attribués conformément au protocole, aux PON, aux règlements, aux lignes directrices applicables et au Plan des opérations cliniques.Collaborer avec les ressources de projet et leur fournir du soutien (ARC/CRA, CTA et équipe de surveillance centralisée).Assurer une documentation complète et exacte de tous les outils et modèles propres aux sites et maintenir les sites prêts pour un audit.Effectuer les activités de surveillance centralisée des sites attribués et évaluer leur qualité et leur intégrité conformément au protocole, aux PON, aux règlements et aux lignes directrices applicables.Assurer l’exactitude et la mise à jour des systèmes internes, bases de données, outils de suivi et rapports relatifs aux renseignements propres aux sites.Gérer les déclencheurs et préparer les trousses i-Site pour les sites et pays concernés dans le cadre des études assignées.Réaliser les activités déléguées et/ou agir comme remplaçant pour les parties prenantes pertinentes au sein de l’équipe de projet.Procéder à des examens périodiques des indicateurs clés de risque (KRI) au niveau des sites et de leur rendement historique conformément au Plan de surveillance centralisée, et fournir des recommandations aux responsables CMS afin de favoriser l’identification précoce des risques et enjeux.Surveiller la performance des sites et recommander des mesures correctives en temps opportun (par exemple, contact téléphonique avec le site ou visite de surveillance sur site déclenchée).Évaluer l’efficacité des mesures recommandées et prendre des mesures additionnelles appropriées lorsque les résultats attendus ne sont pas observés.Travailler conformément au Plan de surveillance centralisée de l’étude.Établir et maintenir des communications efficaces avec les parties prenantes pertinentes au niveau du projet et des sites.Offrir du mentorat aux Moniteurs centralisés associés.Examiner les rapports conformément aux annotations, aux PON et aux lignes directrices; identifier les problèmes, les signaler au responsable clinique, préparer les annotations, donner de la formation aux ARC et animer des rencontres mensuelles avec les parties prenantes pour discuter des principaux enjeux et tendances observés.Agir à titre de spécialiste des solutions techniques (TSS) et de personne-ressource auprès des équipes de projet et des parties prenantes internes afin de recueillir les critères et les exigences.Analyser la complexité des exigences et fournir les estimations d’effort (EAC) ainsi que les délais de réalisation.Examiner le Plan de surveillance centralisée de l’étude.Participer aux réunions de démarrage, aux réunions d’équipe hebdomadaires et aux rencontres avec les clients, au besoin.Respecter les activités clés décrites dans l’Énoncé des travaux (SOW) conformément aux exigences des clients.QualificationsBaccalauréat en sciences cliniques, sciences de la vie, sciences mathématiques ou dans un domaine connexe, ou diplôme en sciences infirmières.ExigencesMinimum de deux (2) années d’expérience professionnelle pertinente ou combinaison équivalente d’études, de formation et d’expérience.Les nouveaux diplômés détenant un diplôme en médecine ou dans un domaine paramédical connexe peuvent également être considérés.Expérience en recherche clinique, un atout.Le niveau d’expérience requis peut varier selon les exigences particulières des clients.Connaissance approfondie de la conduite des essais cliniques et capacité à appliquer les exigences réglementaires applicables à la recherche clinique.Connaissance des lignes directrices de la Conférence internationale sur l’harmonisation – Bonnes pratiques cliniques (ICH-GCP) ainsi que des lois, règlements et lignes directrices locales applicables aux essais cliniques.Bonne maîtrise des systèmes cliniques.Excellentes aptitudes en communication écrite et verbale, incluant une bonne maîtrise de l’anglais.Approche axée sur les résultats et souci du détail dans l’exécution du travail et la production des livrables.Compréhension des données cliniques et médicales.Bonnes aptitudes en motivation, influence et coaching.Capacité à travailler sur plusieurs projets simultanément et à gérer des priorités concurrentes.Connaissance approfondie des domaines thérapeutiques et des protocoles.Excellentes aptitudes organisationnelles et en résolution de problèmes.Solides compétences en présentation.Capacité démontrée à livrer des résultats conformes aux exigences de qualité et aux délais établis.Capacité à travailler dans un environnement multiculturel et international, avec une bonne compréhension des différences culturelles, tout en maintenant des relations de travail efficaces avec les collègues, les gestionnaires et les clients.**To be eligible for this position, you must reside in the same country/sales region where the job is located. **Location: Canada, Home-BasedJob OverviewManage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts. To ensure the work is conducted as per SOPs, Policies and Good clinical practice’s and applicable regulatory requirements. Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines.Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards. Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOPs, International Conference on Harmonization - Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance. Develop and use of study management plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study. Support project management team to develop monitoring strategy including monitoring triggers/thresholds. Manage the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)Essential Functions• Manage assigned sites and perform Subject Level Data Review independently, if required perform with both responsibilities as dual role.;• Perform remote monitoring visits for assigned sites as assigned.;• Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;• Perform Study specific analytics based on applicable study specific plans. Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value.;• Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;• With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;• Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.;• Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;• Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;• Ensure complete and accurate documentation of all the site-specific tools and templates and keep the sites audit ready.;• Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.;• Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the Site-specific information.;• Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;• Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team.;• Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).;• Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).;• Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.;• Work in accordance of the Study Central Monitoring Plan.;• Establish and maintain effective project/ site level communications with relevant stakeholders.;• Provide Mentorship to Associate Central Monitors.;• Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;• Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.;• Analyze the complexity of the requirements and provide the EAC hours and turn around time.;• Review of the Study Central Monitoring Plan• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested• Adhere to the key activities outlined in the SOW as per customer requirements.Qualifications• Bachelor's Degree Bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, or nursing qualification. Req• Requires minimum of 2 years of relevant work experience or equivalent combination of education, training and experience.• Fresher with Medical or Allied medical degree.• Experience in clinical research field preferred.• Experience level may vary based on customer specific requirements.• Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements.• i.e. International Conference on Harmonization - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.• Good Clinical system expertise.• Strong written and verbal communication skills including good command of English language.• Results and detail-oriented approach to work delivery and output.• Understanding of clinical/medical data.• Good motivational, influencing, coaching skills.• Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.• Strong organizational and problem-solving skills.• Effective presentation skills.• Demonstrated ability to deliver results to the appropriate quality and time line metrics.• Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.**To be eligible for this position, you must reside in the same country/sales region where the job is located. **Location: Canada, Home-BasedIQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez https://jobs.iqvia.com IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au workday_recruiting@iqvia.com, afin qu’IQVIA puisse soutenir votre participation au processus de recrutement.IQVIA s’engage à faire preuve d’intégrité dans son processus de recrutement et applique une politique de tolérance zéro en matière de fraude des candidats. Toutes les informations et toutes les qualifications soumises dans votre candidature doivent être véridiques et complètes. Toute fausse déclaration, présentation trompeuse ou omission importante au cours du processus de recrutement entraînera la disqualification immédiate de votre candidature, ou la cessation d’emploi si elle est découverte ultérieurement, conformément aux lois applicables. Nous apprécions votre honnêteté et votre professionnalisme.Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: workday_recruiting@iqvia.com, so that IQVIA can support your participation in the recruitment process.IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.La fourchette salariale de base potentielle pour ce poste, annualisée, est de $61,400.00 - $102,400.00. Le salaire de base réel offert peut varier selon plusieurs facteurs, notamment les qualifications liées à l’emploi telles que les connaissances, les compétences, la formation et l’expérience; l’emplacement; et/ou l’horaire (temps plein ou temps partiel). Selon le poste offert, des régimes d’incitation, des primes et/ou d’autres formes de rémunération peuvent être proposés, en plus d’une gamme d’avantages sociaux liés à la santé, au bien-être et/ou d’autres bénéfices. The potential base pay range for this role, when annualized, is $61,400.00 - $102,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and wellness and/or other benefits.This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemote
Job Openings Senior Associate, Senior Data Manager, Clinical Data Sciences About the job Senior Associate, Senior Data Manager, Clinical Data Sciences Job Title: Senior Associate, Senior Data Manager, Clinical Data Sciences Job Location: Argentina - Buenos Aires Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Application Instructions: Please submit your resume in English when applying.Work Location Assignment: Buenos Aires, Argentina (Complejo LUMINA – Office Park). This role follows a hybrid model. Colleagues are expected to work from the assigned Pfizer office 2–3 days per week, or as required by business needs.Use Your Power for PurposeOur mission is straightforward: support healthcare decisions that ensure the safe and effective use of medications. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.What You Will AchieveIn this role, you will:Serve as Lead Data Manager for one or more clinical trials assuming responsibility for CDS activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities.Independently lead the daily DM activities and allocate study DM resource in the appropriate way.Coach junior Data Managers in the study and perform peer review of study DM's deliverables for quality control.Be responsible to achieve the study DM milestone on time with good quality.In collaboration with the Clinical Data Scientist, ensure operational excellence across all CDS deliverables.Ensure work carried out in accordance with applicable SOPs and working practices.Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.Ensure operational excellence in collaboration with CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross study learning.Be capable to contribute on the DM related continuous improvement activitiesHere Is What You Need (Minimum Requirements)Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCPDemonstrated knowledge of data management processes and principles in area of responsibility.Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol reviewDemonstrates strong verbal and written communication skills including ability to communicate remotelyMinimum 3 years Data Management experience requiredWorking knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirementsProficient experience using commercial clinical data management systems and/or EDC products (e.g. , Inform preferred)Experience using data visualization tools (e.g. Spotfire, J-Review) preferredFamiliarity with MedDRA/WHO-DrugProficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)Bachelor’s degree minimum requirement. Experience of project management skill in terms of resource management and timeline and quality control preferred.Bonus Points If You Have (Preferred Requirements)Master's degreeRelevant pharmaceutical industry experienceExperience using data visualization toolsProficient experience using commercial clinical data management systems and/or EDC productsAwareness of regulatory requirements and relevant data standardsStrong analytical and problem-solving skillsAbility to work collaboratively in a team environmentExcellent organizational and time management skillsExperience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical useEEO (Equal Employment Opportunity) & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemoteSenior
General Information Job Title Associate – Data Engineer (Data Business CoE) Job ID 107698 Work Areas Analytics, Data & Research Employment Type Permanent Full-Time Location(s) New Delhi Description & Requirements About usBain & Company is a global management consulting that helps the world’s most ambitious change makers define the future. Across 65 offices in 40 countries, we work alongside our clients as one team with a shared ambition to achieve extraordinary results, outperform the competition and redefine industries. Since our founding in 1973, we have measured our success by the success of our clients, and we proudly maintain the highest level of client advocacy in the industry.In 2004, the firm established its presence in the Indian market by opening the Bain Capability Center (BCC) in New Delhi. The BCC is now known as BCN (Bain Capability Network) with its nodes across various geographies. BCN is an integral and largest unit of (ECD) Expert Client Delivery. ECD plays a critical role as it adds value to Bain's case teams globally by supporting them with analytics and research solutioning across all industries, specific domains for corporate cases, client development, private equity diligence or Bain intellectual property. The BCN comprises of Consulting Services, Knowledge Services and Shared Services.Who you will work with Pyxis combines alternative data, AI-driven analytics, and institutional investor-led insights to reveal where, how and why consumers buy, how they pay, how much they spend, how their needs and demands are changing, and much more. By revealing previously opaque fundamental business trends and their drivers, Pyxis enables investors and business decision makers to efficiently allocate capital and address critical problems.Pyxis has assembled one of the most comprehensive collections of alternative data covering hundreds of millions of people and tens of billions of transactions across the U.S., Canada, Brazil, UK, France and Japan as well as targeted countries across the EU and APAC. This data provides a longitudinal view of consumer and business transactional behaviors—across nearly all verticals over the last six years—and plays an integral role in answering companies’ and investors’ questions about market share, category size, pricing and promotion effectiveness, assortment optimization, ad targeting, loyalty, switching behavior, disruption, and more.These state-of-the art capabilities enable Bain to provide its clients with a valuable new dimension in investment analysis and strategy development, complementing Bain’s proven “outside-in” approach with the ability to apply complex data sets to assess company fundamentals. BCN Pyxis modeler will work closely with the BCN team manager, Pyxis Product Manager, General Manager, Bain Partners, and the Proprietary Data group to build and deliver a commercially successful product that spans core sectors across all regions. The working style of the team would be to support Pyxis product development , hence the pipelines and algorithm built should be scalable and automated to support subscription clientsWhat you’ll do Design, implement, and continuously expand data pipelines by performing extraction, transformation, and loading activitiesWork across workstreams to deliver high-quality, zero-defect deliverables and leverage manager’s support on complex piecesGather requirements and business process knowledge in order to transform the data in a way that’s geared towards the needs of end usersProvides tool based technical expertise to the junior team members when requiredBuilds reusable capabilities that can be used by team members or across service linesWrite advanced SQL and Python code to build and maintain backend data APIs and services; work hands-on with Snowflake for data transformation, query optimization, and pipeline developmentEnsure that the data architecture is scalable and maintainableDesign and develop RESTful backend APIs and microservices using Python (FastAPI/Flask) to expose data products and support downstream consumersWork with the business in designing and delivering correct, high quality dataInvestigate data to identify potential issues within ETL pipelines, notify end-users and propose adequate solutionsPrepare documentation for further reference Respond to onshore team/client questions around the data and insightsProvide ongoing support for subscription customers, such as additional data cuts and responding to questions about the data/methodologyThe working style of the team would be to support product development , hence the pipelines and algorithm built should be scalable and automatedAbout youWork experience: 6-8 years of experience in areas related to Data Management, Business Intelligence or Business Analytics. Hands-on experience in data handling and ETL workstreamsEducation Required: Incumbent should be a graduate/post graduate from top-tier institute or have pursued a statistical/analytical course from a tier 1 universityPreferred: Concentration in a quantitative discipline such as Statistics, Mathematics, Engineering, Computer Science, Econometrics, Business Analytics, or Market Research is strongly preferred. Knowledge, Skills and Abilities Required:Design, develop, and maintain scalable data pipelines using Python and SQL for batch and real-time data processing.Build and optimize ETL/ELT workflows to ingest, transform, and load data from multiple source systems.Develop and maintain RESTful APIs and data services using FastAPI for data integration and consumption.Design, implement, and support enterprise-grade Data Warehouse solutions following dimensional modeling best practices.Create and optimize complex SQL queries, stored procedures, and data transformations for analytics and reporting.Work extensively with Snowflake to build, optimize, and manage cloud-based data platforms (good to have)Utilize Starburst/Trino for distributed query processing, data federation, and high-performance analytics (good to have)Ensure data quality, consistency, and reliability through validation frameworks, monitoring, and automated testing.Optimize data pipeline performance, query execution, and storage utilization across large-scale datasets.Collaborate with business stakeholders, data analysts, and engineering teams to gather and translate data requirements.Implement data governance, security, access controls, and compliance standards across data platforms.Troubleshoot production data issues, perform root-cause analysis, and implement preventive solutions.Leverage cloud-native technologies and best practices for scalable, resilient, and cost-effective data architectures.Maintain technical documentation, data lineage, and operational runbooks while following Agile development methodologies.What makes us a great place to workWe are proud to be consistently recognized as one of the world's best places to work, a champion of diversity and a model of social responsibility. We are currently ranked the #1 consulting firm on Glassdoor’s Best Places to Work list, and we have maintained a spot in the top four on Glassdoor's list for the last 12 years. We believe that diversity, inclusion and collaboration is key to building extraordinary teams. We hire people with exceptional talents, abilities and potential, then create an environment where you can become the best version of yourself and thrive both professionally and personally. We are publicly recognized by external parties such as Fortune, Vault, Mogul, Working Mother, Glassdoor and the Human Rights Campaign for being a great place to work for diversity and inclusion, women, LGBTQ and parents. Go back Apply Share this job: LinkedIn X Emailfull timeMid Level
Job Openings Clinical Data Engineering Lead About the job Clinical Data Engineering Lead Job Title: Clinical Data Engineering Lead Job Location: Cambridge (USA), Massachusetts Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Job ID REQ-10064031 Jun 22, 2026 USA Available in: English Summary About the role:#LI:OnsiteAre you ready to make a lasting impact by building the future of oncology research? Novartis Biomedical Research (NBR) is searching for a visionary Associate Director to lead Clinical Data Engineering within our Oncology Data Science (OncDS) team. In this pivotal role, you’ll be at the forefront of shaping early clinical development by building innovative biomarker data infrastructure, championing translational research, unlocking AI-powered discoveries, and raising the bar for operational excellence in biomarker data and multimodal analytics across Novartis’ oncology trials. About the Role Key responsibilities:Define and implement the clinical data engineering roadmap in alignment with Novartis’ data and digital strategy, collaborating with SMEs and OncDS leadership.Integrate advanced tools and AI/ML-ready infrastructure to support predictive modeling, multimodal analytics, and real-world data applications.Align clinical and pre-clinical data engineering initiatives with the broader oncology strategy.Lead, manage, and develop a high-performing clinical data engineering team, fostering collaboration and growth.Drive strategic initiatives and partnerships across a matrixed organization.Oversee data ingestion, transformation, and validation processes for clinical trial data, ensuring compliance with GCP/GxP, CDISC, and SOPs.Collaborate with CROs and internal teams to optimize data flow, versioning, and retention policies.Build and optimize data pipelines for both structured and unstructured clinical data to enable advanced analytics and informed decision-making.Deploy scalable solutions for data harmonization, metadata management, and interoperability across platforms such as Foundry, Domino, Snowflake, and POSIT Connect.Develop and manage applications and visualization tools, contributing to novel data products that support clinical decision-making and enable AI-driven initiatives in oncology trials.Essential Requirements:This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require 0-3% travel as defined by the business (domestic and/ or international).Master's degree in computer science, Bioinformatics, Data Engineering, Software Engineering or a closely related discipline; PhD preferred.Minimum 10 years of hands-on experience architecting and managing clinical data engineering, data management, and bioinformatics solutions in pharmaceutical or biotechnology industry.Demonstrated expertise in designing, implementing, and scaling data infrastructure to support clinical development—including Artificial Intelligence (AI) / Machine Learning (ML) -driven analytics and multimodal data integration.Proven ability to define, document, and operationalize end-to-end assay data generation and processing pipelines, with a focus on automation, orchestration, and compliance.Extensive experience with oncology clinical trials, including regulatory-compliant management of clinical biomarker data and application of data standards (e.g., Clinical Data Interchange Standards Consortium [CDISC], Study Data Tabulation Model [SDTM], Analysis Data Model [ADaM]).Deep familiarity with FAIR (Findable, Accessible, Interoperable, Reusable) data principles, data harmonization, and enterprise data governance frameworks.Strong leadership in technical teams, with advanced communication and stakeholder management skills.Desirable requirements:Extensive experience leading cross-functional data science initiatives in oncology, including translational science, biomarker analysis, real-world data, and exploratory clinical research; proven expertise with NGS technologies, and modern bioinformatics tools.Advanced proficiency in cloud-native architectures, data lakes, and visualization frameworks (e.g., RShiny, Dash, Spotfire); strong programming and engineering skills (R, Python, Java, shell scripting, Linux, HPC), with a deep understanding of GxP, Agile methodologies, AI/ML operations, and architecting/managing AI agents in large clinical data environments.The salary for this position is expected to range between $176,400 and $327,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.Read our handbook (PDF 30 MB) EEO Statement:The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.Accessibility & Reasonable AccommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemoteLead$327.6K
Job Openings Clinical Data Associate I/II - Serbia - Remote About the job Clinical Data Associate I/II - Serbia - Remote Job Title: Clinical Data Associate I/II - Serbia - Remote Job Location: Virtual Serbia Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Who we areWe’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!What the Data Management Department does at Worldwide Our Data Management team is an ever-growing and collaborative group of diverse individuals with wide-ranging experience within the industry. From start to finish, we are involved in clinical studies – from crafting the study database to ensuring the pristine delivery of the final dataset. We meticulously ensure data accuracy and integrity, crucial for groundbreaking regulatory submissions. With a variety of roles, from data support staff, database and SAS programmers, coders, and functional leads, there are many opportunities to launch and further your career. Our team embraces an environment that invites input, fosters personal growth, and empowers your professional journey. What you will do To assist the Data Manager in all data cleaning activities. To assist the Data Manager with the preparation of trial documentation. To perform verification and User Acceptance Testing of configured databases. To assist the Data Manager with the creation and validation of Manual and SAS checks. To assist the Data Manager with the reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory). Responsible for the registration of users into the EDC/CTMS system, performing system demonstrations if required. To assist with the maintenance of procedure logs, coding schemes, input notes and Data Entry Manuals. What you will bring to the role The job holder must be computer literate and numerate with a willingness to adapt to various computer systems. It is essential that the job holder works with close attention to detail and is questioning about the validity of the data being entered and has an ability to phrase data queries in an understandable and impartial manner. To have the ability to train new staff and to monitor their performance. Your experience Educated to a degree level (preferably Life Science). We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemote