Project Director I / II
Core
Plan and execute or oversee clinical trials for biotech and pharmaceutical companies, ensuring delivery on time, within budget, and in accordance with regulatory guidelines while managing a team of Project Managers and Associates.
Role type
Senior IC clinical project director (CRO)
Builds
Clinical trial projects (FIH, HV, Phase 1 & 2) for emerging biotech companies
Domain
Clinical research / Biotechnology / Pharmaceuticals
Required skills
Clinical trial project management, team leadership, sponsor communication, risk management, financial management, regulatory compliance (ICH GCP), vendor management, staff recruitment and performance management
Preferred skills
Experience with Serious Adverse Event reporting, audit participation, privacy legislation understanding
Technologies
Clinical trial management systems, company SOPs, financial forecasting tools
Responsibilities
Coordinate staff and processes to deliver projects on time and within budget; provide guidance to Project Managers; manage sponsor communication and grievances; develop study plans and documents; identify and report study-specific risks; manage project finances including invoicing and vendor payments; manage line reports' compliance, training, and performance; recruit and manage staff; manage contracted services and vendors; participate in audits; ensure Serious Adverse Events are reported.
Seniority
Senior, hands-on IC with line management responsibilities