Main purpose
Do you have a passion for both project management and line management? Harmony Clinical Research is looking for you! Currently we have a vacancy for a combined position as Project Manager and CRA Team Lead.
On the one hand, you are responsible for the end-to-end management of our full-service clinical trials, which means that you not only manage the Clinical Operations part, but also the activities for medical writing, regulatory activities, data management, statistics, pharmacovigilance, medical monitoring, …
On the other hand, you are responsible for a team of (currently) 8 CRAs. You are involved in selection, onboarding, training and coaching of our CRAs. In close collaboration with the Clinical Operations Manager and QA Coordinator, you contribute to the improvement of our processes.
Responsibilities
As Project Manager:
- 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).
As CRA Team Lead:
- To manage resourcing, staff retention, training and capacity needs.
- To manage performance and skills development of all internal CRAs.
- To ensure accurate identification and implementation of client and project requirements.
- To bear end responsibility for all aspects of delivered monitoring services.
- To stay abreast of new developments and regulations in the industry and ensure that operational processes and standards reflect those developments.
- To ensure close communication and coordination between CRAs and PMs.
Tasks
As Project Manager:
- 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.
As CRA Team Lead:
- To ensure adequat training programs (introductory and during employment) for the CRAs.
- To supervise capacity planning for monitoring activities.
- To perform co-monitoring visits.
- To act as first-line helpdesk for the CRAs.
- To follow-up on the quality of the monitoring activities.
- Any required activity to ensure a good integration of both Belgian and Dutch team of CRAs.
- To review and improve existing SOPs and to develop new SOPs if needed for monitoring activities.
Job criteria
Degree in life science, preferably higher vocational education or academic degree
Previous experience as PM in (international) clinical research is required.
Experience with oncology clinical trials is a plus.
Fluent in English and Dutch; 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 preference for a fulltime position.
- 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 occasionally (nationally and internationally if applicable)
- Talented and passionate human
- Believer of the principles of Customer-Centricity, Human Centricity, Growth mindset, Enterprise view and Diversity and Inclusion
- You thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational.
- You apply your organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operation’s programs, studies, and/or enabling projects.
- You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener.
- You thrive leading or being an active member of large or small diverse teams.
- You find passion in achieving successful outcomes by inspiring others.
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