EMEA Clinical Research Leader

10 ore fa

Italia W. L. Gore & Associates A tempo pieno
Clinical Reseach Leader

We are looking for a Clinical Research Leader to join our team. In this role, you will provide business direction, vision, and leadership to the EMEA Clinical team. Primary responsibilities are to support and mentor clinical team, composed by 10 members, and to assist them in the successful management and efficient and effective functioning of Clinical Affairs. In addition, to providing leadership to the EMEA Clinical team, you will also closely collaborate with the EMEA leadership team to bring the Clinical perspective into leadership discussions, you will act as a strong partner to the EMEA Business Group Leaders (Aortic, Peripheral, Cardiac/Surgical Solutions) to support EMEA Business needs through clinical activities and will be a strong partner to EMEA Medical Functions Leaders (Regulatory, HE&R, HCP Interaction) to drive EMEA Medical functions strategic goals.

Responsibilities
  • Establish and maintain the strategic direction for Clinical Affairs to assist the Enterprise and Medical Products Division in achieving business goals and objectives.
  • Work closely with divisional and category / business leadership as the key clinical liaison to define and implement long-term strategies for successful pre-market clinical trials and post-marketing initiatives. Participate in process improvement initiatives.
  • Interact (define, assist, prioritize) with regulatory agencies, investigators, and customers in achieving Clinical Affairs strategic goals.
  • Work closely with Clinical Teams to meet project, functional, and divisional goals.
  • In partnership with Clinical functional team leaders, oversee all aspects of clinical studies including study viability and selection, research progress, data collection, and communication of outcomes, ensuring these are accomplished according to applicable regulations and Good Clinical Practices.
  • Assume responsibility for departmental budget planning and execution.
  • Oversee quality initiatives and ensure organizational compliance with FDA/European Competent Authorities rules and regulations and divisional Quality Systems.
  • Oversee selection of project CROs, Core Labs and other clinical trial vendors, including consultants.
  • Serve as Contribution / Compensation Representative for Clinical Affairs Associates.
  • Drive and manage change through strong professional leadership skills and maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position.
Required Qualifications
  • Bachelor's degree required, preferably in health sciences, bioengineering, or life sciences.
  • Five year experience in clinical research in the IDE / medical device arena
  • Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint)
  • Strong organizational skills, flexibility, and ability to multi-task
  • Strong verbal and written communication skills
  • Ability to manage and mentor
  • Experience working on and leading cross-functional teams
  • Ability to travel up to 20 %
Desired Qualifications
  • Advanced degree preferred
  • Multi-disciplinary experience preferred

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