Clinical Trial Manager

IQVIA; Madrid; Presencial; EUR 80.000 - 100.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Clinical Trial Manager in Madrid to join our sponsor-dedicated Clinical FSP team. You will provide input on trial implementation, manage timelines and budgets, and liaise with internal stakeholders and vendors to execute high-quality trials.

You will lead site selection, feasibility, recruitment planning, and risk mitigation, coordinating cross-functional teams to ensure trials run on time and within budget. Regulatory experience and strong communication are essential.

Formación

• Minimum 4 years’ experience in biopharmaceutical industry.
• Minimum 3 years of global Clinical Project Management experience.
• Proven work experience and knowledge of Oncology.
• Bachelor’s Degree or relevant science-based degree.
• Ability to manage multiple priorities across several protocols and therapeutic areas.
• Strong experience in vendor management and regulatory knowledge (ICH GCP).
• Experience executing a wide range of clinical trial activities from initiation to CSR.

Responsabilidades

• Deliver trials on time, within budget, and with high quality.
• Develop and write clinical trial documents (Protocol, CRFs, ICF, CSR).
• Lead evaluation and selection of investigative sites; responsible for feasibility.
• Coordinate and monitor vendor activities and co-monitoring visits.
• Develop and manage trials timelines, budget, and priorities.
• Participate in data review and discrepancy resolution.
• Ensure systems are in place to plan and track trials and progress.
• Generate reports to update management on trial conduct.
• Ensure recruitment plans and risk-mitigation plans are developed.
• Participate in monitoring study safety and review key quality metrics.
• Lead multidisciplinary trial teams and study team meetings.

Conocimientos

Communication skills

Vendor management

Multitasking

Global trial management

Regulatory knowledge

Oncology knowledge

Clinical trial management

Educación

Bachelor’s Degree or science-based degree

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_