The Clinical Project Manager (CPM) is responsible for the setup, the execution of a clinical trial and the generation of clinical data supporting registration of the IMP on a defined Market. This will be done as per the defined timelines and the budget.
- Define study timelines, sets milestones and track study progress against endorsed plans,
- Contribute to Study operational feasibility (interaction with CROs, Key opinion leaders,),
- Responsible for coordinating the preparation of the clinical dossier in support to the Medical Director and the Study manager (writing of the study documents, contracts negotiation, define the key documents for submission.),
- Accountable for the preparation of study documents (CRF, monitoring guidelines, safety guidelines, any study specific procedures),
- Coordinates the input/deliverable of the different contributing teams (monitoring CRO, pre-clinic, production and medial Affairs),
- Ensure all the country specific requirement are shared with the study team, followed-up on and timely met (safety or regulatory matters),
- Perform in-process control all along the study setup up to reports are disclosed,
- Ensures that study is conducted in compliance with study protocol, with ICH- GCP and that safety, right and well-being of patients are preserved,
- Maintain study timelines and budget within the agreed plan by monitoring progress (interaction with SM and Monitors and use of ms project, budget plan) and in case of deviation, putting suitable contingency plan,
- Responsible for ensuring Data are produced and collected with quality by using management tools (risk management, protocol deviation management,),
- Participates to the blind review meeting, reviews the study results provided by statistical team, reviews and inputs on the CSR draft version to final,
- Ensure that the services agreed between the company and the service provider are delivered accordingly, Active contribution as per needs in Scientific advices, Advisory boards, scientific meeting, Support the Regulatory Manager and the Safety manager in tasks such as DSUR / PIP / RMP / SmPC /MAA Dossier by Providing material for the writing to the MW (+ review) and Coordinate filing).
Education and Skills
- Master or PhD in life sciences or equivalent scientific background,
- Minimum of 5 year experience in clinical research,
- Fluency in English (written and oral),
- Analytic and synthetic capacity,
- Adaptability to fast changing environment & Solution oriented,
- Effective presentation skills,
- Ability to manage competing priorities,
- Strong software and computer skills, including MS Office applications,
- Ability to establish and maintain effective working relationships with coworkers, managers and clients,
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines,
- Strong communication and interpersonal skills, including good command of English language,
- Strong organizational and problem solving skills,
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
We are a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. We have a headcount of 22 staff members, located at our headquarters and in the laboratory.