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We are seeking an experienced Clinical Operations Manager to lead the operational execution of a large multicentre, prospective study. The role will oversee all clinical site activities, vendor management, regulatory compliance, and study timelines, ensuring delivery to scope, schedule, and budget.
As the primary operational contact for clinical sites and service providers, the Clinical Operations Manager will coordinate across internal teams and external partners to ensure the study is executed according to GCP, appropriate regulations, and sponsor SOPs. This is a strongly external-facing position, requiring regular interaction with academic sites, CROs, and specialized vendors.
The role sits at the intersection of clinical research, logistics and project management, vendor oversight, and precision medicine — making it a key contributor to our scientific and operational success.
**Main Missions**:
- **Vendor & Stakeholder Management**:
- Serve as the primary point of contact for external partners (academic centres & CROs)
- Organize and lead regular update meetings to coordinate all stakeholders involved
- **Project Management & Reporting**:
- Develop and maintain study timelines, risk mitigation plans, and communication flows
- Track and report on study progress, including enrolment, protocol deviations, sample issues, and vendor deliverables
- Manage study budget and invoicing
- **Clinical Operations Oversight**:
- Lead day-to-day management of a multicentre clinical study
- Oversee CROs’ activities related to site activation, monitoring, and data management
- Coordinate site engagement, recruitment performance, and issue resolution
- **Biosample & Data Coordination**:
**o Coordinate the end-to-end logistics of data & biosample flow - from collection to shipment, processing, storage, and quality control - across external partners (sites and vendors).**
- Develop and enforce SOPs for biosample handling and data reconciliation
- **Quality, Compliance & Documentation**
- Ensure compliance with GCP, relevant regulations (e.g. GDPR), and internal SOPs
- Lead regulatory submissions and ethics committee communications with support from Legal
- Maintain study documentation up to date
In addition, as we operate in a startup environment, we value adaptability. You may occasionally be asked to contribute to tasks outside of your core responsibilities. We estimate that up to 5% of your time may be dedicated to company-wide collaborative efforts.
**Who we are looking for**
- Master’s degree in life sciences, Pharm D, public health, or related field
- 5+ years of experience in clinical study management, preferably including biosample and omics components
- Proven track record managing multi-site studies and working with external CROs and vendors
- Familiarity with clinical trial regulations (ICH-GCP, GDPR) and biosample governance
- Strong knowledge of study operations workflows: site initiation, EDC, monitoring, sample logistics, data reconciliation
- Excellent organizational, problem-solving, and communication skills
- Full proficiency in English
**How to stand out**
- You have high agency, look for solutions rather than problems and you are a team-player willing to go beyond your job description
- You are familiar with a start-up environment
- You have previously worked in the immuno-inflammation space
You are familiar with precision medicine and artificial intelligence
Type d'emploi : Temps plein, CDI
Statut : Cadre
Rémunération : 26 086,84€ à 77 966,67€ par an
Avantages:
- Prise en charge du transport quotidien
- RTT
- Travail à domicile occasionnel
Lieu du poste : En présentiel
