Senior Clinical Project Manager

Excelya Group; Paris; Sur place; EUR 85 000 - 115 000; Plein temps

Résumé du poste

Excelya Group is seeking an experienced Clinical Project Manager to lead local clinical activities in pharmaceutical environments in Paris. You will oversee study start-up through close-out, ensuring alignment with global timelines and quality standards.

Your role requires strong autonomy, rigorous attention to data quality, and fluent communication with investigators, CROs, vendors, and cross-functional teams across geographies. French and English bilingual capabilities are essential.

Qualifications

• Experienced in Clinical Operations within pharma or CRO.
• Experience as Clinical Project Manager or Study Manager.
• Involvement in interventional trials (Phase II–IV).
• Solid understanding of ICH-GCP and regulatory environment.
• Experience collaborating with investigators, CROs, and cross-functional teammates.
• Strong organizational, operational and communication skills.

Responsabilités

• Lead and coordinate clinical trial activities at the local level from start-up to close-out.
• Ensure local execution of global study plans in alignment with timelines and quality standards.
• Serve as the key point of contact for local investigational sites and regional stakeholders.
• Ensure that clinical trial activities comply with local regulations, ICH-GCP, and internal SOPs.
• Coordinate local submissions to authorities and ethics committees as required.
• Monitor regulatory timelines and manage corrective actions.
• Support site activation, monitoring and close-out with CRAs and vendors.
• Manage relationships with local vendors (logistics, labs, CROs).
• Track recruitment progress, performance, and site-level metrics.
• Collaborate with global study teams, medical/regulatory affairs, and clinical operations.
• Participate in study meetings and provide updates on local activities.

Connaissances

Clinical operations

Clinical project management

Regulatory compliance

Cross-functional collaboration

Multitasking

Communication skills

French & English fluency

Description du poste

We are seeking an experienced Clinical Project Manager to oversee and coordinate clinical activities in pharmaceutical environment.
The role involves managing operational aspects of clinical trials, ensuring compliance with regulatory requirements, and acting as the primary interface between local stakeholders, investigators, vendors, and global teams.

This position requires strong autonomy, rigor, and excellent communication skills, with the ability to navigate cross-functional environments.

Key Responsibilities :

1. Study Management

• Lead and coordinate clinical trial activities at the local level from start-up to close-out.
• Ensure local execution of global study plans in alignment with timelines and quality standards.
• Serve as the key point of contact for local investigational sites and regional stakeholders.

2. Regulatory & Compliance Oversight

• Ensure that clinical trial activities comply with local regulations, ICH-GCP, and internal SOPs.
• Coordinate local submissions to competent authorities and ethics committees when required.
• Monitor adherence to regulatory timelines and manage any corrective actions.

3. Site & Vendor Coordination

• Support site selection, activation, monitoring, and close-out in collaboration with CRAs and vendors.
• Manage relationships with local vendors (logistics, labs, CRO partners).
• Follow up on recruitment progress, performance, and site-level metrics.

4. Cross-Functional Collaboration

• Work closely with global study teams, medical affairs, regulatory affairs, and clinical operations.
• Participate in study meetings and provide updates on local activities, challenges, and achievements.
• Support risk mitigation plans and operational troubleshooting.

5. Data Quality & Operational Tracking

• Oversee data accuracy, query resolution, and compliance of documentation.
• Track KPIs, patient recruitment, timelines, and operational deliverables.
• Contribute to audit and inspection readiness.

• Experienced in Clinical Operations within pharma or CRO.
• Experience as Clinical Project Manager, Study Manager, or equivalent.
• Previous involvement in interventional trials (Phase II-IV preferred).
• Solid understanding of ICH-GCP, regulatory environment, and local clinical research practices.
• Experience collaborating with investigators, CROs, and cross-functional teammates.
• Strong organizational, operational, and communication skills.
• Ability to manage several tasks simultaneously in a fast-paced environment.
• Fluency in French and English (written & spoken).

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.

Here’s what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our "one-stop provider" service model - combining full-service, functional service provider, and consulting - allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.