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Clinical Project Manager (m/f/i) - West Europe

Job Description Summary

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. BD helps customers to enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Our location in Karlsruhe deals with the development and manufacture of minimally invasive products.

Job Description

About the position

The Clinical Project Manager (m/f/i) - West Europe is responsible for the execution of global clinical strategies generating clinical evidence for non-active and active medical devices (class II/III).

Main Tasks:

  • Management of overall study activities in accordance with the protocol, 21 CFR/ISO14155 and internal SOPs

  • Preparation of study documents, including, protocols, CRFs, Informed Consent Forms, budgets and project plans

  • Selection and management of external service providers

  • Effective communication with investigational sites and other internal/external stakeholders

  • Responsibilities:

  • Design and execute clinical trials and further types of data collection (pre-market, post-market clinical follow up)

  • Understand regulatory requirements for medical device studies in GER/AUT/SUI and larger EU countries

  • Prepare documents and obtain approvals from Ethics Committees and Competent Authorities

  • Manage clinical device supplies and logistics

  • Train site personnel (incl. Investigator Meetings), internal study team and vendor CRAs on device and study procedures

  • Ensure full compliance with safety reporting requirements according to applicable regulations

  • Participate in Site Initiation Visits and Monitoring Visits depending on project needs

  • Ensure timely enrollment and data collection in liaison with investigational sites and global Clinical Affairs

  • Assist in the preparation and review of study reports

  • Assist in regulatory submissions to Notified Bodies and international authorities

  • Collaborate with Clinical/Regulatory Affairs, Quality, R&D and Marketing departments

  • About you

    University degree (BSc, MSc, PhD) in Life Sciences, Medical Technology, Medicine, Pharmacy or related field.

    Furthermore, you have:

  • 5-year experience in clinical research in the medical device/pharmaceutical industry, CRO, or public research institution with relevant project experience

  • Excellent communication skills inEnglish (oral and written), a further EU language German, French, Italian is a plus

  • Proven Project Management experience in conducting multi-center clinical studies

  • Experience with study regulatory submissions

  • Ability to understand regulatory requirements and advanced device technology

  • Sound knowledge of MS office, open to take advantage of state of art technology

  • Good teamwork capabilities and effective reporting

  • Willingness to travel (20%)

  • Our Offer

  • Working in a global organization and with highly motivated teams

  • A familiar work climate in an innovative environment where your input counts

  • A safe workplace with long-term perspectives.

  • Flexible working from office or remote

  • Company Car

  • We endeavor a long-term collaboration – hence corporate career planning throughout diverse phases of life conveys a high importance and value for us

  • Work Location

    Home office based

    Clinical Project Manager (m/f/i) - West Europe

    BD, Olen
    Contract Type: 
    Home working
    Categories: 
    Project Manager
    Degree Level: 
    PhD
    Bachelor
    Master
    Career level: 
    Manager