Raynham, Massachusetts, United States of America / West Chester, Pennsylvania, United States of America / Palm Beach Gardens, Florida, United States of Americafull timeSenior
verified Jun 6, 2026posted 3 months ago
Showing 25+ verified jobs
query:GCP Compliance Manager - Global Clinical Operations
United Kingdom - LondonRemotefull time
posted 21 days ago
Remote / San Francisco, United States / Seattle, United StatesRemoteDirector$210K–235K
posted 2 months ago
Ireland - DublinRemotefull time
posted 21 days ago
Issy-les-Moulineaux, Francefull timeLead€53.5K–53.5K
posted 2 months ago
Montreal, Canada
posted 5 days ago
London, United Kingdomfull timeDirector£83.5K–155.1K
posted 20 days ago
Raritan, New Jersey, United States of America / Spring House, Pennsylvania, United States of America / San Diego, United Statesfull timeSenior
posted 18 days ago
Remote, PolandRemoteSenior
posted last month
Remote, PolandRemoteSenior
posted last month
Dublin, Irelandfull timeDirector€90.3K–90.3K
posted 19 days ago
Job Openings Director, Global Clinical Process Management Lead About the job Director, Global Clinical Process Management Lead Job Title: Director, Global Clinical Process Management Lead Job Location: Remote (US) Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description: The role is responsible for leading and supporting global clinical process management activities within GCO, ensuring that processes, standards, and related procedural documents are efficient, consistent, sustainable, and compliant with applicable regulatory requirements. The incumbent serves as a key liaison between GCPM, GCO Regional Heads, regional organizations, Global Process Owners, Subject Matter Experts, and cross-functional partners to support process development, revision, adoption, and implementation. The role contributes to continuous improvement by translating process changes into practical business implications, consolidating regional feedback, escalating key concerns or recommendations, and assessing local or regional regulatory and operational impacts on global processes. In addition, the incumbent may act as Global Process Owner for assigned documents, lead review and approval workflows, contribute to process-related training strategy and materials, and mentor selected Associate Directors to support capability development and consistent process leadership. Responsibilities:Drive the execution of global clinical process management activities within GCO, ensuring processes and standards are efficient, consistent, sustainable, and compliant with applicable regulatory requirements.Serve as the primary GCOE point of contact for one or more assigned GCO processes, including related SOPs, work instructions, and standards.Contribute to the development of GCO procedural content in collaboration with Global Process Owners and Subject Matter Experts and may act as Global Process Owner for assigned documents, including SOPs, work instructions, templates, and tools.Lead GCO process management initiatives, assessing the need to revise or create controlled documents and supporting continuous improvement, change management, and effective implementation.Lead document review and approval workflows to ensure timely progression, appropriate stakeholder engagement, and alignment with governance expectations.Act as advisor and reviewer for processes owned by other functions that impact GCO processes, standards, and ways of working.Establish and maintain effective partnerships with relevant GCO teams and cross-functional stakeholders, including GCP Compliance, Learning and Development, and other groups as required.Contribute to the development, strategy, and implementation of training materials related to GCO processes.Serve as the primary communication liaison between GCO Regional Heads, their organizations, and the GCPM team for processes under development or revision.Support effective adoption of new or revised processes by translating process changes into practical business implications for regional and local teams.Partner with Regional Head organizations to consolidate feedback, promote alignment, and support a coordinated regional perspective on process adoption.Escalate regional positioning, concerns, or recommendations to the Head of GCPM and the relevant GCPM Process Lead to enable appropriate follow-up, decision-making, and collaborative resolution.Relay key local and regional insights, including changes in local regulations or operational requirements, to assess and address potential impacts on global processes within GCPM scope.Mentor selected Associate Directors within GCPM, as assigned by the Head of GCPM, to support capability development, role effectiveness, and consistent process leadership. Requirements: Fluent English (Oral; Written)Relevant bachelor’s degree minimum – preferred science/healthcare disciplineMinimum of 8 years of experience in pharmaceutical and/or biotechnology sectorExtensive knowledge of clinical operations process, ICH-GCP and compliance management; including application of clinical trial regulation/sExperience in clinical trial process design, harmonization/optimization and implementation.Experience working in matrix environment and in global teamsExcellent interpersonal, problem-solving, negotiation and conflict resolution skillsExcellent organizational skills and a pre-disposition to quality management and process improvementEffective communicator (oral and written)Strong presentation skillsEducation Required: Bachelor’s degree required, master’s or other relevant post graduate qualification preferred.Global CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range: $171,900.00 - $231,900.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected] 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 EmailRemoteDirector$231.9K
posted 10 days ago
High Wycombe, Buckinghamshire, United Kingdomfull timeSenior
posted 18 days ago
Allschwil, Basel-Country, Switzerlandfull timeSenior
verified 6d agoposted 18 days ago
Beerse, Antwerp, Belgium / Issy-les-Moulineaux, France / Milan, Italy / Duelmen, Germany / Madrid - Lafinca / Warsaw, Polandfull timeMid Level€6M–6M
verified 4d agoposted 18 days ago
Jersey City, NJ; Millbrae, CASenior
posted 12 days ago
Job Openings Senior Global Clinical Study Manager About the job Senior Global Clinical Study Manager Job Title: Senior Global Clinical Study Manager Job Location: Remote (US) Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:At BeOne, our Global Development SuperHighway — our integrated, end-to-end, wholly internal development capability — is a cornerstone of our R&D vision. It brings together a unique set of internal cross-functional capabilities from across the globe needed for efficient delivery of clinical trials to develop impactful medicines to accelerate access to innovation for patients around the world.We are now opening this same delivery engine to the world’s most promising external science. Through SuperHighway partnerships, highly promising assets from leading biotech partners can access our development capabilities creating a true win-win ecosystem with the ultimate goal of helping more patients around the world. This is not a fee-for-service model; it is a bold new way to grow the company and expand what’s possible in oncology. This is a rare opportunity to help build something genuinely new — joining a high-caliber, agile team at the leading edge of clinical development innovation. If you are energized by building, by challenging the status quo, and by making a real impact on patients’ lives, this is where you belong.Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality for studies within our partnership programs under the Clinical SuperHighway.Leads all aspects of assigned clinical study(ies).Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies).Ensures alignment of study goals with clinical operations and corporate goals and objectives.Contributes to development of global tools and standards, leads the development of work instructions and SOPs as required.This role helps deliver the partnership studies that run on our Clinical SuperHighway, supporting seamless onboarding and high-quality execution of external partner projects in close partnership with the execution functions.Essential Functions of the Job:Cross-Functional LeadershipLeads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues.Leads external vendors management involved in study delivery.Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives.Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required.Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings.Participates and presents at various topics of Clinical Study Management.Participates in Clinical Operations Process improvement initiative. Planning and ExecutionLeads planning and management of the assigned clinical study(ies) from feasibility through closeout activities.Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these.Ensures that the clinical studies are operationally feasible along with Global Clinical Program Lead, oversees trial feasibility, trial allocation and site selection process across all regions.Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs.Provides oversight to study start up and site activation plans.Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriately.Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems.Implements RBQM end-to-end processes on time within the allocated study (e.g., periodic reviews, centralized monitoring analyses, action items).Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed.Ensures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC plan.Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites.Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders.Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members. Quality and Risk ManagementMonitors study activities to ensure compliance with the study protocol, SOPs, all study plans, ICH/GCP and all other relevant regulations.Regularly reviews and manages quality-related GCO metrics to be within acceptable limits.Ensures inspection readiness at any point in time throughout the study life cycle.Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented.Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented.Prepares team for quality assurance audits and inspections.Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared.Leads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies.Leads development, optimization and review of work instructions and SOPs as required. Budget and ResourcesWorks with the sourcing team to select and manage study vendors, approving invoice payment throughout the study.Manages study budgets, including baseline budget evaluation, change control, study closure budget, presents study budget for senior management engagement.Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts.Identifies and manages study team resource needs and establishes contingency plans for key resources.Monitors Clinical Study Team resource utilization over the study life cycle.Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters.Supervisory Responsibilities: N/A (CST-level role; no people-management responsibilities). Computer Skills: MS Office; Project Planning Applications; Clinical Trial Management Systems (CTMS)Other Qualifications:Proven Project Management experience in Global Clinical Studies (Oncology experience preferred).Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes.Able to independently lead global clinical studies.8 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.Education Required:Bachelor’s degree in a scientific or healthcare discipline required (exceptions may be made for candidates with relevant clinical operations experience); higher degree preferred.Global CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClaritySalary Range: $136,400.00 - $181,400.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected] 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$181.4K
posted 10 days ago
South San Francisco, United Statesfull timeSenior$90/hr
posted 11 days ago
San Mateo, CA United StatesSenior$160K–210K
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Hanoi City, Hà Nội, 1000000full time
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London, United Kingdom
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