For our clients in Switzerland, France, Germany and other European countries, we are proactively looking for Clinical project managers. Both a first experience, as well as senior professionals are welcome!
- Are you fluent in English?
- Do you have a scientific background, and industry experience as clinical project manager?
- Are you open to relocate if required, and willing to work on temporary projects?
Don’t hesitate and send us your cv. We are happy to take the time to get to know you.
The Clinical Project Manager (CPM) is responsible for the set-up and progress of a clinical trial/study within the allocated countries, ensuring compliance with company quality standards and regulations in force, the forecasted timelines, milestones and budget.
You represent the countries in his/her perimeter at the global Clinical Trial Team.
You ensure liaison with other Clinical Trial Team members.
You lead the monitoring teams in the designated countries for his/her trials.
- Is accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs/IRBs/HAs, approvals, contracts with sites)
- Is responsible that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, closure of sites, archiving)
- Is the first point of contact for other global Clinical Trial Team members and the local monitoring teams
- Is the first point of contact for Medical Affairs for locally initiated studies, providing input to feasibility, study design and budget development and providing feedback on study progress
- Organizes kick-off meeting with local monitoring teams
- Organizes training of monitoring teams (study procedures, study devices, monitoring plan,...)
- Organizes investigators meeting
- Provides support to monitoring teams (protocol, monitoring plan, CRF, tools... )
- Prepares or arranges the preparation of protocols, written subject information, other essential documents, CSR, etc. for studies initiated locally
- Ensures the preparation of local study AED within/across the countries
- Ensures optimization of costs, and manages the country study budget
- Ensures the implementation of study IT systems in the countries (IVRS, ePortal)
- Ensures adequate provisioning of devices and materials in the countries enough in advance
- Participates in the revision/preparation of study progress tools (newsletters,...)
- Ensures CTMS are updated appropriately
- Sources and manages service providers (e.g. Medical Writer, Statistician, Data Manager, Central Laboratory, CRO, etc.)
- Oversees field monitoring activities through regular contacts with local monitoring teams (e.g. local CTT meeting), review of MVRs, checks on monitoring tool compliance
- Identifies potential problems (risks) and ensures issues are solved with action plans in place (recruitment, study conduct/data quality,...)
- Ensures high quality level in data collection and queries resolution for the countries
- Conducts appropriate accompanied site visits
- Ensures preparation and proper response to audit/inspection reports and implementation of recommendations
- Shares lessons learned and ensures adequate deployment of possible identified action plans for improvement within/across the countries
- Educated to degree level in a science or medical specialty
- Knowledge of clinical trial design and development, a minimum of 3 years of Clinical project manager experience is required
- Thorough working knowledge of all aspects of GCP and the regulatory/ethical framework pertaining to clinical trials
- Ability to plan, set and manage clinical trial budgets
- Ability to learn and apply SOPs
- Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting
- Management, leadership, negotiation skills and communication skills
- Organizational, analytical and planning abilities, able to prioritize
- Results oriented, quality preserving, be proactive and able to anticipate and resolve conflicts/issues
- Fluent in English, knowledge of another European language (French, Dutch, German,...) is considered an asset