Contractor PM-Tigermed Jyton-France

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

Résumé du poste

A clinical trials management company in Lille is seeking an experienced project manager for clinical trials. This role involves drafting project management and monitoring plans, managing site activities, and maintaining positive client relationships. The ideal candidate has over 5 years of clinical trial experience, including 3 years in independent project management, as well as fluency in English. Strong project and time management skills are essential.

Qualifications

• Bachelor degree or above in Medical, Pharmacology or Biology.
• Adequate knowledge of medical device development, including local regulation, GCP.
• Fluent in both written and oral English.

Responsabilités

• Draft and implement project management plan according to applicable regulations.
• Draft and implement monitoring plan for CRA training and site monitoring.
• Manage site feasibility, selection, initiation, monitoring, and close-out activities.

Connaissances

Project management

Communication skills

Information-gathering skills

Time management

Formation

Bachelor degree in Medical, Pharmacology or Biology

Outils

Microsoft Office

Description du poste

Overview

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

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 is 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 on 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.

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) Language
  Fluent in both written and oral English.
• (e) IT Skills
  Good command of Microsoft Office.
• (f) Other abilities
  Communication skills, information-gathering skills. Strong project management skill; strong time management skill.