04 ago
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Discover International
|
Barcelona
04 ago
Discover International
Barcelona
ph3Principal Executive Search Consultant - Medical Clinical /h3 h3Clinical Project Manager – Phase I PK/PD Bioequivalence Studies (Generics) /h3 pLocation: Spain /p pEmployment Type: Full-time, Permanent /p h3About Us /h3 pI'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. /p h3About the Role /h3 pWe are seeking an experienced bClinical Project Manager (CPM) /b to lead and oversee bPhase I pharmacokinetic (PK/PD), pharmacodynamic (PD), and bioequivalence (BE) /b 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. /p h3Key Responsibilities /h3 ul liLead the planning, execution, and close-out of Phase I PK/PD and BE clinical studies. /li liManage study timelines, budgets, and deliverables to ensure projects are completed on time and within scope. /li liServe as the primary point of contact for sponsors, clinical sites, and internal teams. /li liOversee protocol development, CRF design, and operational planning for bioequivalence studies. /li liEnsure adherence to ICH-GCP,
regulatory guidelines (FDA, EMA, MHRA, etc.), and company SOPs. /li liMonitor project performance metrics and proactively address risks and deviations. /li liCollaborate with bioanalytical, data management, and biostatistics teams to ensure seamless data flow and reporting. /li liSupport audits, inspections, and quality assurance activities. /li /ul h3Requirements /h3 ul liBachelor’s degree (or higher) in Life Sciences, Pharmacy, or related field. /li li3–5+ years of experience managing Phase I clinical trials, ideally within a Pharmaceuticals, Biotech or CRO or generic drug development environment. /li liProven track record in PK/PD and bioequivalence studies. /li liStrong knowledge of GCP, ICH, and regional regulatory requirements. /li liExcellent organizational, communication, and leadership skills. /li liAbility to manage multiple studies simultaneously in a fast-paced setting. /li /ul h3Seniority Level /h3 ulliMid-Senior level /li /ul h3Employment Type /h3 ulliFull-time /li /ul h3Job Function /h3 ulliScience /li /ul h3Industries /h3 ulliPharmaceutical Manufacturing and Biotechnology Research /li /ul pReferrals increase your chances of interviewing at Discover International by 2x /p /p #J-18808-Ljbffr
📌 Clinical Project Leader (Barcelona)
🏢 Discover International
📍 Barcelona