Clinical Project Manager

Jobtailor

Paris

Sur place

EUR 80 000 - 110 000

Plein temps

14 jours+

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Résumé du poste

Jobtailor in Paris, France, seeks an experienced Clinical Trial Manager to coordinate feasibility assessments, startup activities, and end-to-end oversight of European clinical trials. The role involves regulatory submissions, CRO coordination, and ongoing study governance across sites.

The ideal candidate will have strong knowledge of ICH-GCP guidelines, CTIS experience, and fluency in English, with excellent stakeholder management and budget oversight capabilities.

Qualifications

Experience as Clinical Trial Manager or equivalent.
Strong knowledge of clinical trial processes.
Experience with CTIS submissions in Europe.
Excellent communication and stakeholder management.
Fluent English.

Responsabilités

Coordinate feasibility assessments and interactions with investigators, experts, and stakeholders.
Lead the start-up, implementation, and oversight of clinical trials.
Support regulatory submissions and study maintenance via CTIS.
Review country-specific study documents for regulatory compliance.
Monitor KPIs, metrics, and dashboards to track study performance.
Coordinate CROs, vendors, and investigational sites.
Organize and lead study meetings with proper documentation.
Monitor patient recruitment, site engagement, and progress.
Identify risks and implement mitigation plans.
Manage study budgets and track financial performance.
Provide on-site support to investigational sites when required.
Oversee close-out activities, including site closure and database lock.

Connaissances

Clinical trial mgmt

CTIS submissions

Regulatory compliance

Budget management

Stakeholder management

Project management

CRO coordination

English fluent

Formation

Life Sciences degree

Outils

CTIS

Description du poste

Coordinate feasibility assessments and interactions with investigators, experts, and key stakeholders.
Lead the preparation, start‑up, implementation, and operational oversight of clinical trials.
Support regulatory submissions and study maintenance activities through CTIS.
Review and oversee country‑specific study documentation to ensure regulatory compliance.
Monitor study KPIs, metrics, and dashboards to track study performance.
Coordinate external monitoring providers and administrative support vendors.
Organize and lead study meetings, ensuring appropriate documentation and follow‑up of action items.
Monitor patient recruitment, site engagement, and overall study progress.
Identify study risks and implement mitigation plans to ensure successful delivery.
Manage study budgets and track financial performance.
Provide support to investigational sites through on‑site visits when required.
Oversee study close‑out activities, including site closure, database lock, and study archiving.

Requirements

Life Sciences, Pharmacy, Nursing, or a related scientific field.
Previous experience as a Clinical Trial Manager, Local Study Manager, Clinical Project Manager, or equivalent role.
Strong knowledge of clinical trial processes, including start‑up, conduct, and close‑out.
Experience with CTIS submissions and regulatory processes in Europe.
Good understanding of ICH‑GCP guidelines and clinical trial regulations.
Experience coordinating CROs, vendors, and investigational sites.
Strong project management, risk management, and budget management skills.
Excellent communication and stakeholder management abilities.
Fluent English (written and spoken).

Core Competencies

Demonstrates expertise in managing clinical trials, including feasibility assessments, regulatory submissions, and compliance with ICH-GCP guidelines. Proficient in project management, risk management, and budget oversight while ensuring effective communication with stakeholders.

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