Clinical Project Leader

hace 2 semanas

Barcelona, Barcelona, España Discover International A tiempo completo

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.

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