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.