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 :

Bachelor’s degree (or higher) in Life Sciences, Pharmacy, or related field.

3–5+ years of experience managing Phase I clinical trials, ideally within a Pharmaceuticals, Biotech or CRO or generic drug development environment.

Proven track record in PK / PD and bioequivalence studies.

Strong knowledge of GCP, ICH, and regional regulatory requirements.

Excellent organizational, communication, and leadership skills.

Ability to manage multiple studies simultaneously in a fast-paced setting.