Clinical Trial Manager

IQVIA; Barcelona; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA in Barcelona, Spain is seeking a Clinical Trial Manager to oversee trials across therapeutic areas. You will manage timelines, budgets, feasibility, site selection, and recruitment plans, acting as the primary liaison for internal stakeholders and vendors.

Ideal candidates have 4+ years in biopharma, global clinical project management experience, and strong regulatory knowledge (ICH-GCP). This on-site role offers the chance to lead multi-disciplinary teams.

Formación

• Minimum of 4 years’ experience in the biopharmaceutical industry.
• Minimum 3 years' experience in Clinical Project Management at global level.
• Experience in 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

• 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.

Conocimientos

Clinical trial management

Vendor management

Regulatory knowledge (ICH-GCP)

Project coordination

Educación

Bachelor’s Degree in Science

Descripción del empleo

Reading, Berkshire, United Kingdom

Zagreb, Croatia

Lisbon, Portugal

Barcelona, Spain

Prague, Czech Republic

Madrid, Spain

Full time

R1566767

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 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.

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 a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

_Please note This role is not eligible for UK visa sponsorship_