Contractor PM-Tigermed Jyton-France (MJ000037)

Tigermed; Nantes; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A clinical research organization in Nantes is seeking a Project Manager for clinical trials. This role involves managing project plans, monitoring, and client relationships. The ideal candidate will have over 5 years of clinical trial experience and strong project management skills, along with a Bachelor's degree in a related field and fluency in English. A GCP certificate is required, and familiarity with medical device regulations is a plus.

Qualifications

• At least 5 years clinical trial experience.
• At least 3 years of independent project management experience.
• Experience of at least 3 medical device clinical trials.
• GCP certificate required.
• Fluent in both written and oral English.

Responsabilités

• Draft and implement project management plan according to regulations.
• Draft and implement monitoring plan according to regulations.
• Manage site feasibility, selection, initiation, monitoring, and close-out activities.
• Maintain positive relationship with sponsors and investigators.

Connaissances

Project management

Communication skills

Information-gathering skills

Time management

Formation

Bachelor degree in Medical, Pharmacology or Biology

Outils

Microsoft Office

Description du poste

1. Job Purpose

To implement project management of clinical trials effectively, and to ensure success of clinical trials.

2. Responsibilities

• Make the project management plan : To draft and implement feasible project management plan according to SOPs , ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure the trial in managed under the project management plan.
• Make monitoring plan : To draft and implement monitoring plan according to SOPs , ICH GCP Guidelines, ISO14155 and other applicable regulations. Ensure CRA is trained of the monitoring plan and the site is monitored based on the monitoring plan.
• Manage site feasibility, site selection, initiation, monitoring, and close‑out activities.
• Client Maintenance : Keep positive relationship with sponsor and investigator.

3. Minimum Qualifications

a) Academic / Major

Bachelor degree or above in Medical, Pharmacology or Biology related majors.

b) Professional Skills

Adequate knowledge of medical device development, including local regulation, GCP. GCP certificate required.

(c) Working Experience

At least 5 years clinical trial experience, at least 3 years of independent project management experience. Experience of at least 3 medical device clinical trials.

(d) Fluent in both written and oral English.

(e) Good command of Microsoft offices.

(f) Other abilities such as Communication skills\Information-gathering skills. Strong project management skill; Strong time management skill.