Job Description Summary
Your responsibilities :
Independently, you prepare and / or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.
g., clinical protocols, Informed Consent Forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Study Procedure Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
You ensure execution within overall study timelines and deliverables and deliver accordingly for your studies.
You collaborate actively with other GCD functions, e.g. global project management, as applicable, DM and Statistics & with the Medical Affairs departments of the BD Business Units
You oversees / lead and train study-specific local clinical resources, e.g. contractor CRA, CRO, etc.
You manage studies for different Business Units and provide critical thinking when issues arise during execution of clinical studies.
You contribute to continuous improvement activities / initiatives and function as GCD Contact Person
You manage relationships with sites / PIs and other study-related vendors, e.g. CROs, central labs, etc.
You have good knowledge of established project management standards so you are able to plan and track regional study tasks accordingly.
You define, track and report on project management schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff
Your profile :
Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas
Minimum of 2 years clinical project management experience
Minimum 4 years of clinical study experience, (e.g., preferably in medical device, IVD or biotechnology industry) including the proven ability to oversee clinical teams in the conduct and report of multicenter, complex studies
Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations, including MDR and IVDR
Strong communication skills & client / vendor relationship management skills
Demonstrable Project Management skills; PMP certification is a preferred goal for all BD Clinical Project Managers
Fluency in verbal and written English language; fluency in additional languages is a plus
Ability to travel approximately 20%, worldwide
What can you expect from us?
A varied function with international contacts within a company with an important social contribution in a value-driven organization.
An informal working atmosphere, dynamic corporate culture and an environment that lets you grow and develop.
An attractive remuneration package
Interested? Apply now!