BD (Becton, Dickinson and Company) Clinical Project Manager in Heidelberg, Germany
Job Description Summary
Introduction to our company:
Global Clinical Development (GCD) is part of the Medical Affairs organization of Becton, Dickinson and Company (BD), which strives, with more than 65.000 employees in 150+ countries, to advance the world of healthcare. We do this by providing technological solutions that improve the efficiency in healthcare, increase the safety and decrease the healthcare cost.
The role of GCD in the organization is to provide any services in human subject research where needed globally. Ensuring quality study execution to meet regulatory and commercial goals, in the desired, and/or most cost-effective geography. GCD is supporting all Business Units within BD and is therefore involved in the execution of clinical studies with a broad range of products. GCD provides support for study execution, data management, statistics and medical writing.
Who are we looking for?
The Clinical Project Manager working within the European Clinical Operations team as part of the Global Clinical Development (GCD) organization, is responsible for clinical trial management of multiple studies in countries in Europe. He/she may function as local subject matter expert for a group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCD or Contract Research Organizations (CRO). This role serves as the local project lead in a multitude of countries for studies of various complexity and supports protocol development through study conduct and closeout in compliance with Good Clinical Practices, global, national and local regulations, BD and GCD policies, and SOPs. The role reports to the Senior Manager, Clinical Portfolio Management at GCD and collaborates with respective Medical Affairs departments of different BD Business Units and other global GCD functions, e.g. Data Management and Statistics, Site Management and Monitoring and other GCD Project and Portfolio Managers to ensure an aligned planning and optimized trial execution.
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
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!
Primary Work Location
AUT Vienna - Handelskai, AUT Wien - Rinnböckstrasse, BEL Erembodegem - Dorp 86, CHE Eysins - Business Park Terre-Bonne, DEU Heidelberg - Tullastrasse, DEU Karlsruhe, FRA Le Pont-de-Claix Cedex, FRA Rungis Cedex - Bâtiment Londres, ITA Rome, NLD Drachten - Marconilaan
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.