Clinical Operations Lead

Job Title: Clinical Operations Lead Job Location: Reading, Berkshire, United Kingdom Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.The Clinical Operations Lead supports the Clinical Trial Operational team in execution of the trials. The position maintains effective communication with project team through correspondence and status reports to ensure alignment with study timelines. The COL includes direct liaison with CROs and other vendors to manage relevant trial operational lasts.Main ResponsibilitiesAssist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans.Create Master ICF template and review site changes. Update template for new risks and new amendments information.Participate in the feasibility and evaluation of investigative sites.Assist in the development and management of study timelines and priorities, including recruitment tools/ strategy and patient retentions plan.Plan and organize meetings with team support (eg. investigator/ coordinator meetings).Assist in the development of the IP and co-medication strategy.Monitor study specific timelines and key deliverables; focus on management of vendors (eg. Monitoring, Sample management, IVRS, Laboratory).Develop relationships with investigational sites and institutions to enhance conduct of the trial.Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.Required Skills and QualificationsMinimum of 3 years’ experience in the biopharmaceutical industry or other relevant clinical research experience.Minimum 1 year or experience in Clinical Project Management.Proven work experience and knowledge of Oncology therapeutic area.Bachelor’s Degree or relevant degree with strong emphasis on Science.Prior experience in assisting the conduct and management of multinational/ global clinical trials.Strong experience in vendor management.Working knowledge of ICH Good Clinical Practices and other relevant regulatory experience.Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.Strong communication skills with internal teams, sites, and vendors.Please apply with your English CV.Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.*Please note This role is not eligible for UK visa sponsorship 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 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.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.

Job Title: Clinical Operations Lead

Job Title:

Job Location: Reading, Berkshire, United Kingdom

Job Location:

Job Location Type: Remote

Job Location Type:

Job Contract Type: Full-time

Job Contract Type:

Job Seniority Level:

Job Seniority Level:

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.

The Clinical Operations Lead supports the Clinical Trial Operational team in execution of the trials. The position maintains effective communication with project team through correspondence and status reports to ensure alignment with study timelines. The COL includes direct liaison with CROs and other vendors to manage relevant trial operational lasts.

Clinical Operations Lead

Main Responsibilities

Main Responsibilities

• Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans.

Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans.

• Create Master ICF template and review site changes. Update template for new risks and new amendments information.

Create Master ICF template and review site changes. Update template for new risks and new amendments information.

• Participate in the feasibility and evaluation of investigative sites.

Participate in the feasibility and evaluation of investigative sites.

• Assist in the development and management of study timelines and priorities, including recruitment tools/ strategy and patient retentions plan.

Assist in the development and management of study timelines and priorities, including recruitment tools/ strategy and patient retentions plan.

• Plan and organize meetings with team support (eg. investigator/ coordinator meetings).

Plan and organize meetings with team support (eg. investigator/ coordinator meetings).

• Assist in the development of the IP and co-medication strategy.

Assist in the development of the IP and co-medication strategy.

• Monitor study specific timelines and key deliverables; focus on management of vendors (eg. Monitoring, Sample management, IVRS, Laboratory).

Monitor study specific timelines and key deliverables; focus on management of vendors (eg. Monitoring, Sample management, IVRS, Laboratory).

• Develop relationships with investigational sites and institutions to enhance conduct of the trial.

Develop relationships with investigational sites and institutions to enhance conduct of the trial.

• Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.

Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.

Required Skills and Qualifications

Required Skills and Qualifications

• Minimum of 3 years’ experience in the biopharmaceutical industry or other relevant clinical research experience.

Minimum of 3 years’ experience in the biopharmaceutical industry or other relevant clinical research experience.

• Minimum 1 year or experience in Clinical Project Management.

Minimum 1 year or experience in Clinical Project Management.

• Proven work experience and knowledge of Oncology therapeutic area.

Proven work experience and knowledge of Oncology therapeutic area.

• Bachelor’s Degree or relevant degree with strong emphasis on Science.

Bachelor’s Degree or relevant degree with strong emphasis on Science.

• Prior experience in assisting the conduct and management of multinational/ global clinical trials.

Prior experience in assisting the conduct and management of multinational/ global clinical trials.

• Strong experience in vendor management.

Strong experience in vendor management.

• Working knowledge of ICH Good Clinical Practices and other relevant regulatory experience.

Working knowledge of ICH Good Clinical Practices and other relevant regulatory experience.

• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

• Strong communication skills with internal teams, sites, and vendors.

Strong communication skills with internal teams, sites, and vendors.

Please apply with your English CV.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

*Please note This role is not eligible for UK visa sponsorship

*Please note This role is not eligible for UK visa sponsorship

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.com

https://jobs.iqvia.com

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.

This job is curated by Lifelancer.

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.

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.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.