Clinical Trial Manager

IQVIA; Oeiras; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Clinical Trial Manager in Portugal to oversee global clinical trials, with a strong emphasis on Oncology. The role involves managing timelines, budgets, site feasibility, and vendor coordination, while liaising with internal stakeholders and external partners.

You will lead multi-disciplinary teams, develop recruitment and risk-mitigation plans, monitor quality metrics, and ensure compliant trial conduct from initiation through to study report.

Qualificações

• Minimum 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.

Responsabilidades

• 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 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 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 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 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.

Conhecimentos

Clinical project management

Oncology

Vendor management

ICH-GCP

Communication

Formação académica

Bachelor's degree in Science

Descrição da oferta de emprego

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 IQVIA Clinical Trial Manager provides input to the overall operational trials implementation, manages trials timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.

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.

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: 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.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.