Description
We are seeking a Local Clinical Project Manager (Sponsor dedicated) to lead Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
The successful candidate will have overall responsibility for the study commitments within the country and for timely delivery of data to required quality. They will lead a Local Study Team consisting of CRA(s), CSA(s), and ensure compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
Key responsibilities include:
- Leading Local Study Teams at country level
- Ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations
- Coordinating site selection, site qualification visits, and study setup
- Managing study timelines, budgets, and resources
- Overseeing monitoring activities and reviewing monitoring visit reports
- Proactively identifying risks and facilitating resolution of complex study problems and issues
The ideal candidate will have:
- A Bachelor's degree in a related discipline, preferably in life science
- At least a year of experience in Clinical Project Management at Local level
- Very good knowledge of Oncology therapeutic area
- Proven ability to lead and motivate cross-functional teams
- Excellent understanding of the Clinical Study Process including monitoring
- Excellent project management skills
- Strong ability to prioritize and handle multiple tasks
- Very good knowledge of spoken and written English language
- Good ability to learn and adapt to work with IT systems
- Ability to travel nationally and internationally as required