Project Manager II – Clinical Trials (Spain)

About the role

The Project Manager II will lead the full lifecycle of assigned clinical trials, ensuring they are initiated, planned, executed, monitored, and closed successfully. You will act as the primary liaison between the sponsor and internal teams, driving study progress while adhering to SOPs, GCP, and regulatory requirements.

Key responsibilities

• Serve as the main contact for the sponsor, providing timely updates and leading client calls.
• Prepare and oversee study deliverables such as study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.
• Lead study start‑up activities including kick‑off meetings, TMF setup, site selection, activation, vendor onboarding, and budgeting.
• Collaborate with Regulatory Affairs and Data Management to ensure document completeness, CRF alignment, and timely data review.
• Maintain audit‑ready status, monitor quality of deliverables, manage risks, and address discrepancies.
• Control project budget, track internal hours, identify out‑of‑scope activities, and manage change orders.
• Coordinate cross‑functional tasks, report recruitment status, and drive initiatives to meet timelines.

Required profile

• Mid‑level experience managing clinical trial projects, preferably in a CRO environment.
• Strong knowledge of SOPs, Good Clinical Practice, and regulatory requirements.
• Proven ability to manage budgets, timelines, and multi‑disciplinary teams.
• Excellent communication skills with sponsors and internal stakeholders.

Required skills

• Electronic Case Report Form (eCRF) management
• Trial Master File (TMF) setup and maintenance
• Preparation of tables/listings/figures (TLFs)
• Clinical trial budgeting and cost control

What we offer

• Opportunity to work on global Phase III multisite trials.
• Career growth within a mid‑sized CRO.
• Collaborative environment with experienced professionals.