Ref : CPM-2021
Imcyse is a clinical-stage biotech company pioneering the development of a new class of active, specific immunotherapeutics known as Imotopes™. Imcyse’s Imotopes™ hold the promise to cure patients suffering from severe chronic autoimmune diseases for which there is no adequate therapeutic alternative. We are a highly dynamic world-class team dedicated to utilizing our unique Imotope™ technology platform to improve the lives of patients suffering from these debilitating diseases.
For its development Imcyse is looking for a:
Clinical Project Manager (M/F/X)
Within the Clinical Department, the Clinical Project Manager (CPM) is in charge, for one (or more) project(s), of ongoing and future clinical studies. He/She autonomously manages all clinical trial operational aspects in collaboration with internal and external stakeholders. The CPM is the primary interface between Imcyse and all CRO/vendors for ongoing clinical trials regarding issue escalation, financial questions, and management issues. The CPM is responsible for the clinical project budget and coordinates activities among the different stakeholders to ensure deliverables are on-time and on-budget. The CPM is the representative of the Clinical Department in the relevant disease specific cross functional Project Team(s) from the start of the Project (preclinical phase).
For projects that are in clinical phase, the CPM may also become the leader of the cross functional Project Team coordinating project deliverables for assigned project. The CPM is then responsible for ensuring the whole project is completed on-time and on-budget. In such situation, he/she is the representative of the project inside and outside of the company.
Tasks & Responsibilities:
- Participates to the definition of the clinical operational plans and manage their successful and timely execution for assigned trials
- Responsible for the selection and management of vendors, including defining their responsibilities, negotiating the contract in accordance with the related budget
- From clinical study set-up till study archival, ensure that clinical trials achieve on all related objectives and milestones while delivering within established timelines, budget and quality standards, including adherence to ICH, GCP, and all applicable guidelines and regulations
- Manages the clinical study team meetings and coordinates internal and external clinical development activities with all team members involved in the design and conduct of assigned clinical trials
- Contributes to synopsis, protocols and ICFs development
- Manage the related IMP, clinical trial supplies and biospecimen logistic activities
- Participates in the eCRF development
- Participates in study data review and analysis
- Contributes to study report development
- Performs sponsor oversight activities in accordance with GCP throughout the whole study duration
- Proactively anticipates and understands concerns/issues/delays in the project and develops risk assessment and contingency plans. Holds each functional area responsible for associated risk mitigation and management.
- You have a Master’s Degree in life sciences or equivalent experience
- You are operations and results oriented, a problem solver, flexible and team player
- You have excellent communication skills and are fluent in English (written and spoken)
- You have experience Project Management, Clinical Research early phases (minimum of 3 years), outsourcing management
- Your skills and abilities:
- Ability to work autonomously
- Team oriented with excellent interpersonal skills and ability to manage cross functional teams
- Clinical Project management
- Ability to effectively interface with medical personnel at clinical sites and KOL
- Excellent knowledge of GCP
This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
We offer a permanent position in an innovating and dynamic company located near Liège and an attractive salary package in line with the position responsibilities and your experience.
Working conditions : Office work - Home working (maximum 3 days/week)
Your application and related information will remain strictly confidential and will be used in the strict context of this recruitment, in line with GDPR.