Main purpose
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 third party vendors involved in the clinical trial.
Responsibilities
- To bear full responsibility for a clinical trial in terms of progress, timelines, capacity and quality.
- To coach and supervise the project team.
- Act as main line of communication between sponsor, site staff and any third party.
- To ensure that the trial is conducted and documented in compliance with the approved protocol/amendment(s), with Good Clinical Practice (GCP) and with all applicable regulatory requirements.
- To work according to the applicable quality management system (HarmonyCR or client).
Tasks
- To set up the required structures for a clinical trial (administrative and operational).
- To plan and manage the project timelines and resources in accordance with the project budget.
- To ensure the study team is sufficiently trained and that everything is in place for the study team to perform the activities.
- To ensure all required trial 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 trial (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.
- 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.
- To highlight out of scope activities to Business Development.
- Any other task that may be requested as far as can reasonably be expected, including those tasks that are linked to the job description of the Clinical Research Associate (CRA) or the Clinical Trial Assistant (CTA).
Job criteria
Degree in life science, preferably academic degree
Preferably at least 1-2 year experience as PM in (international) clinical research
Fluent in English, Dutch and French; another European language is an asset
Microsoft Office (Outlook, Word, Excel, PowerPoint), internet; any experience with CTMS-, eCRF systems is an advantage
Excellent knowledge of ICH GCP and all applicable regulatory requirements
- 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)
Application form
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