Clinical Trial Manager

IQVIA; Reading; On-site; GBP 60,000 - 85,000; Full time

Job summary

IQVIA, Reading, is seeking aClinical Project Manager to oversee oncology trials across global sites. You will lead cross-functional teams, manage timelines and budgets, and ensure high-quality deliverables from initiation through study report.

The role requires strong ICH-GCP knowledge, vendor management experience, and the ability to handle multiple protocols and priorities in a fast-paced environment. UK-based candidates only; visa sponsorship is not available.

Qualifications

• 4+ years in the biopharmaceutical industry.
• 3+ years in Clinical Project Management at global level.
• Proven oncology therapeutic area experience.
• Bachelor’s degree or relevant science degree.
• Ability to manage multiple priorities across protocols.
• Strong vendor management experience.
• Working knowledge of ICH GCP and regulatory requirements.
• Experience executing trials from initiation to study report.
• Strong communication with teams, sites and vendors.

Responsibilities

• Deliver trials on time, within budget, and with high quality.
• Review, develop and write trial documents including protocols and CRFs.
• Lead site evaluation, selection, and feasibility.
• Coordinate and monitor vendors; review monitoring reports and co-monitoring visits.
• Develop and manage trial timelines, budgets, and priorities.
• Participate in data review and discrepancy resolution.
• Set up and maintain systems to plan and track trials.
• Generate management reports on trial conduct.
• Ensure recruitment, risk mitigation, and contingency plans.
• Lead multidisciplinary trial teams and study meetings.

Skills

Clinical Project Management

Oncology experience

Vendor management

ICH GCP knowledge

Global trials experience

Communication skills

Education

Bachelor’s Degree in Science

Job description

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.

Main Responsibilities

• Accountable to deliver trials on time, within budget, and with highest achievable quality.
• Assist in review, development and writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Lead the evaluation and selection of investigative sites; responsible for feasibility.
• Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co-monitoring visits, as needed.
• Develop and manage trials timelines, budget and priorities.
• Participate in data review and discrepancy resolution.
• Ensure set up and maintain all systems in order to plan and implement trials and track progress.
• Generate reports to update management on conduct of trial.
• Ensure appropriate clinical trial supply plans are implemented and managed.
• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
• Participate in monitoring study safety.
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc) and determine appropriate action in conjunction with study team.
• Assist with CRA and third party vendor training on protocols and practices.
• Lead the multi-disciplinary trials teams; include the study team meetings.

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.

Required Skills And Qualifications

• Minimum of 4 years’ experience in the biopharmaceutical industry.
• Minimum 3 year or experience in Clinical Project Management at global level.
• Proven work experience and knowledge of Oncology therapeutic area.
• Bachelor’s Degree or relevant degree with strong emphasis on Science.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Strong experience in vendor management.
• Working knowledge of ICH Good Clinical Practices and other relevant regulatory experience.
• Experience in executing a wide range of clinical trial activities from initiation to clinical study report.
• Strong communication skills with internal teams, sites, and vendors.

• 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

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.