CLINICAL PROJECT MANAGER

We're looking for a Clinical Project Manager to manage and coordinate clinical research projects from inception to completion at a fast-growing pharmaceutical company .

Reporting to the Global Clinical Operations Director, and working closely with internal teams, service providers, investigators, and CROs, you will ensure that clinical studies are conducted in full compliance with regulatory requirements, Good Clinical Practices (GCP), and quality standards. Ideally, you have at least three years of experience in clinical study execution and oversight as a Project Manager in a pharmaceutical company or CRO, along with a minimum of three years as a Senior CRA in a CRO. Experience in medical devices and / or neurology is highly valued.

Major accountabilities

• Lead the planning and execution of clinical research projects, ensuring alignment with timelines, resources, and budget.
• Develop detailed project plans, including scope, schedule, milestones, and deliverables, and ensure that project goals are achieved within agreed timelines and financial constraints.
• Manage project risks and issues, proactively identifying potential challenges and providing effective solutions.
• Collaborate with medical, regulatory, and clinical teams to define study protocols, objectives, and outcomes.
• Ensure all clinical study documents (including protocols, informed consent forms, case report forms, IB, IMPD etc) are accurate, up-to-date, and in compliance with regulatory requirements.
• Act as the main point of contact between internal teams, external service providers (CROs), investigators, and regulatory authorities with effective communication.
• Lead and organize regular project meetings and deliver KPIs metrics to the upper management.
• Supervise the quality control of clinical data, ensuring data is managed rigorously.
• Ensure data collected is complete, accurate, and delivered on time.
• Responsible for the review and maintenance of key study documents and their filing as appropriate in Trial Master File (TMF).
• 3 years operational experience of clinical study execution / oversight as a project manager in a pharmaceutical company or CROs AND / OR 5 years developing tasks as a senior Clinical Research Associate in CROs.

Ideal Experience

• Clinical operational oversight experience in therapeutic advanced clinical trials (phases II-III and IV) and non-interventional studies with Investigational Medicinal products. Experience with medical devices is a nice to have.
• Management of multicentric studies in Neurology.
• Strong technical and organizational skills, detailed oriented, thorough knowledge of GCP, Clinical Operations processes, and SOPs from the project management point of view.
• Strong leadership and project management skills, with experience in managing cross-functional teams.
• Ability to handle multiple projects and priorities simultaneously in a fast-paced environment.
• Excellent organizational, problem-solving, and analytical skills.
• Based in Barcelona.

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