Clinical Project Manager Job in Zuid Holland Netherlands
As a key member of the Clinical Development team, you will be responsible for all aspects of the execution and conduct of one or more clinical studies Phases 1 to 3, and lead the Clinical Operations team in Leiden. Successful candidate will be responsible for the management and coordination of clinical operational activities ex-US including the resolution of study and vendor issues to ensure that key study milestones are met. He/she needs the proven ability to lead other team members (initially, 3 direct reports with a perspective to expand considerably).
This position provides an opportunity to join a growing Clinical Development department and contribute substantially to the successful implementation of CNS trials in the area of cognitive deficits, namely Alzheimer’s disease and Schizophrenia, but also other CNS indications. In addition, there is an opportunity to expand your knowledge in the science of research as well as CNS through day-to-day activities and close interactions with the Research groups.
The position
Duties will include but are not limited to the following:
- According to experience level, contributes to the development of trial designs and implementation plans, including risk management on the scientific and practical level
- Independently oversees the day to day management of activities associated with assigned clinical trials from concept to completion of final study report; runs internal and external study team meetings
- Assumes project management responsibilities for assigned clinical studies for project planning, budgeting and expense analysis; manages study budget
- Maintains and ensures the quality and completeness of study master files across programs in compliance with GCP
- Function as primary liaison with vendor and/or CRO regarding project activities and deliverables, including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities.
- Participates in vendor selection process and management, and interact with vendors regarding invoices, preparation and management of work plans and issue resolution
- Reviews and prepares various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochures
- Performs on-site monitoring as needed by GCP and reviews monitoring reports
- Participates in Investigator selection, recruitment and training and provides final recommendations; interacts with study sites during study conduct and evaluates their performance; identifies opportunities for training
The profile
- PhD / PharmD / MD / BA / BS - experience with Central Nervous System is essential
- Must be able to travel, and supervise travel of reporting CRAs.
- Work experience to include a minimum of 6 years clinical trial experience with a solid understanding of functional area responsibilities associated with the clinical development process; monitoring experience a plus
- Good working knowledge of GCP/ICH guidelines and regulatory requirements for clinical trial management.
- Must have proven experience in all facets of clinical project management with strong communication (oral and written), and analytical skills.
- Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently. Drives by the aim to help build a global development team.
- Additional attributes include an ability to multi-task, be flexible, self-structured, and to thrive in a fast-paced environment.
Interested?
If you interested in this position, please send your application to Tanja Bos via Tanja.Bos@kelly.nl . For more information, cal 023 711 1197