Junior Clinical Development- Temporary
Core
Planning, designing, organizing, supervising, and reporting on clinical trials contracted to CROs, with a main focus on pharmacokinetic (PK) and bioequivalence (BE) trials.
Role type
Junior Clinical Development Specialist
Builds
Clinical trial execution plans and reports for PK and BE studies
Domain
Pharmaceutical clinical development
Deliverable
client delivery
Required skills
Clinical trial planning and design, CRO selection and coordination, regulatory guideline compliance (GCP, ICH, EMA, FDA), study documentation preparation and review, cross-functional collaboration, SOP maintenance
Preferred skills
Multicenter trial management, Phase II/III trial support, Health Authority interaction
Technologies
GCP systems, clinical trial management tools
Responsibilities
Support the design and day-to-day management of clinical/preclinical trials; Prepare and maintain documents for clinical strategy and study rationale; Coordinate CROs and external vendors; Review documentation before, during, and after clinical trials; Coordinate internal activities for study conduct; Support interactions with Health Authorities; Collaborate with cross-functional departments; Contribute to GCP system maintenance
Seniority
Junior, 3-5 years experience
