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Corporate Clinical Affairs Manager, EMEA

Job Description

  • Interact with Divisional and Corporate Management Teams, including Research & Development, Regulatory Affairs, Quality, Marketing, Law, Information Technology Solutions and other business partners to define, implement and execute clinical strategies in support of defined objectives;
  • Develop and manage clinical studies, budgets, contracts and resources;
  • Ensure clinical studies are in compliance with protocols, corporate standards, procedures, regulations and Good Clinical Practice guidelines, as applicable;
  • Provide operational input for the design of clinical protocols and case report forms;
  • Participate in the preparation and presentation of clinical study results;
  • Assist in the preparation of clinical reports for regulatory submissions or publications; Lead and participate in multi-disciplinary project teams (including external consultants and vendors) to coordinate all aspects of project and program management;

 

DOE, the Manager, Clinical Affairs EMEA will incrementally:

  • Plan and coordinate Clinical Affairs Operations, projects, resources, timelines and budgets;
  • Provide scientific input for the design of clinical protocols and case report forms;
  • Provide scientific input for the design of clinical protocols and case report forms;
  • Lead the preparation and presentation of clinical study results;
  • Plan and coordinate Clinical Affairs Operations, projects, resources, timelines and budgets;
  • Lead or assist in CA due diligence efforts supporting the acquisition of new technologies and/or organizations;
  • Oversee the preparation of clinical reports for regulatory submissions or publications;
  • Oversee the daily activities of Clinical Affairs Operations personnel;
  • Provides strategic direction in the assessment of relevant new technologies and procedures.  Lead the implementation and deployment of a CTMS, training, and on-boarding new studies and business units as required to meet objectives.

 

Successful Candidate are required to have

  • Five+ years’ experience in the medical device (preferred), pharmaceutical or biotechnology industry, with proven results in leading high performance teams delivering pre- and postmarket clinical studies supporting successful regulatory submissions.
  • Bi/multi-lingual oral and written proficiency in German, French, Italian, Spanish and/or Dutch.
  • Postgraduate Degree (MBA, MPH, MS, MD, PhD or equivalent) in a health science or related field, preferably with a focus on clinical research, medicine, operations, technology and/or project management.
  • One or more years of experience with oncology, peripheral vascular, surgery, and urology medical devices is preferred;
  • Proficient knowledge of regulations related to clinical trials;
  • Strong project management skills, attention to detail, and effective organizational skills;
  • Demonstrable proficiency with Microsoft suite of applications;
  • Ability to travel 30%.
     
 
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