Clinical Trial Manager

**About us**:
CellProthera is a French biotech, member of BioValley, whose primary mission is to develop a personalized advanced therapy medicinal product (ATMP) to improve the quality of life of myocardial infarction patients. The company has developed a cell expansion technology platform, recognized by the BSI through ISO 13485 certification, to produce large quantities of purified stem cells: the ProtheraCytes®. The injection of this bio-medicine, tested in a Phase I/IIb clinical trial, enables the structural and functional regeneration of severe post-infarction cardiac lesions. CellProthera's next objective is to launch a Phase III clinical trial and test the action of ProtheraCytes® in other indications, such as ischemic stroke.

In this context, CellProthera is looking for a qualified and motivated **Clinical Trial Manager** to join the dynamic team in the MSC department.

**Position Summary**:
As a Clinical Trial Manager, you will play a pivotal role in the planning, execution, and management of clinical trials. You will ensure that all clinical trial activities are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs. Your expertise will contribute to the successful development of new therapies and medical devices that can make a significant impact on patients' lives.

Under the responsibility of the Chief Medical Officer, your main tasks will be to:

- Oversee the planning, implementation, and management of clinical trials from initiation through close-out
- Develop and manage study timelines, budgets, and resources to ensure efficient and effective trial conduct
- Coordinate with cross-functional teams including Regulatory Affairs, Data Management, Biostatistics, and Medical Affairs
- Ensure compliance with all regulatory requirements and GCP guidelines
- Prepare and review study-related documents including protocols, informed consent forms, and case report forms
- Select, manage, and oversee Clinical Research Organizations (CROs) and other external vendors
- Monitor trial progress and provide regular updates to senior management
- Ensure accurate and timely data collection, entry, and reporting
- Conduct site visits and ensure quality control of trial data
- Manage and mentor clinical trial staff.

**Qualifications**:

- Master degree in Life Sciences with training in clinical research
- 5 years of professional experience in clinical research
- In-depth knowledge of clinical trial design, execution, and regulatory requirements
- Strong organizational and project management skills
- Excellent communication and interpersonal skills
- Autonomy and leadership
- Teamwork skills
- English fluent, French is a plus
- Ability to travel as required.

**What we offer**:

- Permanent position based in Mulhouse center, teleworking possible in accordance with company regulations
- Working hours between 80% and 100% possible
- Luncheon vouchers
- Incentive bonus
- Employee savings plans
- An excellent quality of working life.

**Job Types**: Full-time, Permanent
Status: Cadre

**Experience**:

- clinical research: 5 years (required)

Work Location: Hybrid remote in 68100 Mulhouse