Senior Clinical Project Manager

location_onParis, Île-de-France, Francescheduleil y a 16 heures
trending_upNiveau d’expérience:Senior

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.

Requirements

  • 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).

Benefits

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.

Compétences mentionnées


Biotech, Healthcare, Medical Devices, Pharmaceuticals
Paris, Île-de-France, France
excelya.com

Excelya is an independent contract research organization (CRO) that provides comprehensive solutions to biotech, pharmaceutical, and medical device organizations. Founded in 2014 and headquartered in Paris, France, the company has established a significant global presence, operating in 28 countries with a team of over 900 experts. Excelya is dedicated to supporting its clients in delivering life-changing therapies by offering a wide range of services, including full-service CRO, Functional Service Provider (FSP), and resourcing solutions. The company's approach is guided by its core values of Energy, Care, and Audacity, which are embedded in its operational philosophy. Excelya emphasizes a collaborative 'one-team' approach, ensuring that shared success is achieved through close cooperation at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development. This integrated model allows for the creation of bespoke and robust trial solutions across a broad spectrum of therapeutic areas. Excelya's operational excellence is built on a foundation of understanding client needs and a commitment to efficiency and rigorous operational, scientific, and regulatory standards. The company offers a unique, end-to-end model that provides comprehensive expertise both locally and internationally. Its services cover the full spectrum of clinical development, from Phase I trials to post-marketing studies, including biometrics, data science, regulatory affairs, pharmacovigilance, medical writing, and quality assurance. By offering flexible support tailored to the specific priorities of each client, Excelya enables them to focus on their core objectives. The company prides itself on its entrepreneurial spirit and its ability to provide customized solutions that match the scope and specificity of diverse research projects. This commitment to excellence and a people-centric culture aims to foster an environment where employees are encouraged to contribute their natural talents and personal involvement to advance healthcare collaboratively.

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