Clinical Project Manager – Phase I PK / PD & Bioequivalence Studies (Generics) Employment Type : Full-time, Permanent
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. 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.
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.
Oversee protocol development, CRF design, and operational planning for bioequivalence studies.
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.
Bachelor's degree (or higher) in Life Sciences, Pharmacy, or related field.
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Team Lead • Madrid, Madrid, SPAIN