Clinical Project Leader

Clinical Project Manager – Phase I PK / PD & Bioequivalence Studies (Generics)

Location : Spain

Employment Type : Full-time, Permanent

About Us :

I'm working with a forward thinking pharmaceuticals who are known contributors within the Generics field who are specializing in early-phase clinical development and bioequivalence studies for generic pharmaceuticals. They are committed to the CNS area.

About the Role :

We are seeking an experienced Clinical Project Manager (CPM) to lead and oversee Phase I pharmacokinetic (PK / PD), pharmacodynamic (PD), and bioequivalence (BE) clinical trials. This is a hands-on project management role where you'll coordinate cross-functional teams, ensure regulatory and GCP compliance, and drive successful delivery of complex early-phase studies.

Key Responsibilities :

• Lead the planning, execution, and close-out of Phase I PK / PD and BE clinical studies.
• Manage study timelines, budgets, and deliverables to ensure projects are completed on time and within scope.
• Serve as the primary point of contact for sponsors, clinical sites, and internal teams.
• Oversee protocol development, CRF design, and operational planning for bioequivalence studies.
• Ensure adherence to ICH-GCP, regulatory guidelines (FDA, EMA, MHRA, etc.), and company SOPs.
• Monitor project performance metrics and proactively address risks and deviations.
• Collaborate with bioanalytical, data management, and biostatistics teams to ensure seamless data flow and reporting.
• Support audits, inspections, and quality assurance activities.

Requirements :