Not applicable. This position is open for internal work at HarmonyCR.
This function can be partially homebased, but at least 2 days per week office based are required.
The PM plans and coordinates the overall and day-to-day management of a clinical trial. He/she supervises the overall conduct of a clinical trial in terms of progress, timelines, resources and quality standards.
He/she is the principle contact person, internally for the HarmonyCR study team and externally for the client and any 3rd party vendors involved in the clinical trial.
- To set up the required structures for a clinical trial (administrative and operational)
- To ensure the study team is sufficiently trained to perform the activities
- To ensure all required study documents are available (protocol, ICF, manuals, guidelines, …)
- Coordination and planning of capacity, timelines, … to achieve qualitative and timely results
- To supervise the progress of the study (recruitment, monitoring, …)
- To ensure adequate collection and filing of all study (essential) documents
- To coach and supervise the project team
- To supervise the performance of vendors (e.g., data management, statistics, pharmacovigilance, medical monitoring)
- To report adequately and timely the progress of the study to HarmonyCR Management and client
- To proactively discuss any issues which might arise in future (e.g. regarding recruitment, timelines, …)
- To escalate timely any issue and propose the necessary actions
- Any other task that may be requested as far as can reasonably be expected.
- Education: degree in life science, preferably academic degree
- Experience: at least 3-5 year experience as PM in (international) clinical research, strong hands-on experience needed (e.g., completion of EudraCT xml file, UAT eCRF, development project plan), experience with protocol writing is a plus, experience with management of vaccine trials is a strong plus.
- Langugages: fluent in English and Dutch; another European language is an asset
- IT: Microsoft Office (Outlook, Word, Excel, Powerpoint), internet, any experience with CTMS-, eCRF systems is an advantage
- Personal skills: strong motivational leadership skills, pro-active attitude, diplomacy and tactfulness, outstanding communicative skills: oral as well as in writing (one-on-one as well as in group), team player, problem solver and analytical capabilities (critical analysis of information, identifies mistakes and takes appropriate measures), logical and rational when confronted with problems, accurate and organized, acting in a structured way, keeping high level overview, working independently, stress resistant, willingness to travel (nationally and internationally if applicable)