Clinical Project Manager

Location:

Mulhouse – Haut-Rhin, Alsace, France

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

131597477

Posted On:

13 February 2025

Clinical Project Manager

The company has developed a cell expansion technology platform in cardiology. The injection of this biomedicine, tested in a phase I/IIb clinical trial, enables structural and functional regeneration of severe post-infarction cardiac lesions.

This biotech aims to structure and organize phase III of its clinical trial to finalize the development of its flagship drug.

As part of this goal, my client is looking for a qualified and motivated Clinical Project Manager to join the dynamic clinical research team and ensure the organization and overall management of phase III clinical trials.

Job Description:

As a Clinical Project Manager, you will play a key role in the structuring, implementation, and management of phase III clinical trials. You will ensure that all trial activities are conducted in compliance with:

* Regulatory requirements,
* Good Clinical Practices (GCP),
* The company’s Standard Operating Procedures (SOPs).
* Your expertise will be crucial in ensuring the success and proper execution of phase III.

Key Responsibilities:

* Reporting to the Medical Director, you will be responsible for:
* Developing and structuring the organization plan for phase III clinical trials;
* Supervising the setup and smooth running of phase III clinical trials until closure;
* Developing and managing study timelines, budgets, and resources to ensure efficient trial execution;
* Coordinating with cross-functional teams (regulatory affairs, data management, biostatistics, medical affairs);
* Ensuring compliance with regulatory requirements and GCP;
* Preparing and reviewing study-related documents (protocols, informed consent forms, case report forms);
* Selecting, managing, and overseeing contract research organizations (CROs) and other external providers;
* Monitoring trial progress and providing regular updates to senior management;
* Ensuring accurate and timely collection, entry, and reporting of trial data;
* Conducting site visits and ensuring quality control of trial data;
* Managing and supervising clinical trial staff.

Candidate Profile:

* Master’s degree or phd in clinical research or a scientific degree with additional training in clinical research;
* At least 5 years of professional experience in clinical research, ideally with experience managing a phase III trial;
* Deep knowledge of clinical trial design, execution, and regulatory requirements;
* Strong organizational and project management skills;
* Excellent communication and interpersonal skills;
* Ability to work independently and demonstrate leadership;
* Team player;
* Fluent in English;
* Willingness to travel as required.

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