For one of our clients, a clinical research organisation, we are looking for an experienced clinical project manager to start as soon as possible. You have the possibility to work homebased 2 to 3 days a week.
- Are you looking for a new challenge or are you working as a freelancer?
- Do you have experience with phase I and II trials?
- Did you work on projects or are you specialised in atopic dermatitis, infectuous diseases, CNS and/or respiratory diseases?
- Do you have an excellent level of English?
Then don't hesitate any longuer and contact me for more information!
The Project Manager (PM) provides leadership to a cross-functional / multi-national team in the execution of the clinical research projects. He/she contributes to the pre-award process, the development of the study budget and related documents as well as the bid defence meeting, if applicable. He/she develops and manages the overall study planning and implementation and is the primary liaison between the sponsor, the project team, and the different vendors participating in the study throughout the lifecycle of the project. The PM performs general supervision of the project and liaises with the coordinating team member of the different departments involved in the execution of the project in order to ensure the assigned trial is conducted in accordance to the contract and in compliance with i) the applicable regulatory requirements, ii) the pre-defined procedures, iii) the applicable quality standards, and iv) the mutually accepted timelines. It is the responsibility of the PM to manage the project as such that the sponsor’s expectations are met within the constraints of the budget allotted to the project. The PM pro-actively works with project team members to identify potential issues that might impact the execution of the project and/or the budget in any way and provides contingencies to accommodate the needs of the assigned project.
- Serve as the main point of contact for the client and provide overall management of the assigned project(s) as such that the deliverables to the sponsor are met. Act as a liaison between the study sponsor, the project team, the vendors and investigative sites.
- Maintain detailed project planning, update this planning on an ongoing basis and communicate changes to the project team and the sponsor. Monitor performance metrics, ensure timelines and deliverables are agreed upon and adhered to.
- Identify changes in resource needs, identify issues that might delay the project, lead risk management activities and respond promptly to study issues.
- Ensure implementation of outside vendor/supplier procedures, ensure oversight of the performance of CRA's, partner CRI's.
- Ensure health authorities submission/approvals are obtained.
- Review the Clinical Study Report
- Manage and Develop Trial Documentation.
- Participate in the commercial activities together with the sales team and upper management.
- Ensure the trial budget is managed in line with the organizational and the client’s expectations.
- Act as coach for new Project Managers in cooperation with the Head Project Management of the respective region.
- In case of internal project audit, sponsor project audit and/or regulatory inspection, act as primary contact and liaise with QA. Follow up on audit findings.
- Hands-on experience as Clinical Project Manager for a CRO or Sponsor.
- Experience with phase I or II clinical trials.
- Specialised or having a first experience in Atopic dermatitis/Infectious Diseases/Dermatology/CNS/Respiratory .
- International experience (primarily in Europe).
- Excellent level of English is required, Dutch/French is not necessary.
- Available for at least 60% or more. Working full time is possible.
- Good communication and people management skills.
- Strong problem solving, leadership, organizational skills.
015 21 11 04