Manager Clinical Research (m/f/d)

☞ Fresenius Medical Care

View: 161

Update day: 22-10-2024

Location: Bad Homburg Hesse

Category: R & D IT - Software

Industry: Hospitals Health Care

Position: Associate

Job type: Contract

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Job content

Your assignments

  • Developing studies/study programs for innovative therapies or a defined therapeutic field within the Clinical Research department

  • Providing scientific medical input for the preparation, coordination and approval of the study protocol and accompanying documents

  • Collaborating on the preparation of project plans for the operational implementation of clinical studies

  • Coordinating, monitoring and managing compliance with regulatory requirements and official regulations

  • Within the scope of responsibility, coordinating and communicating the study portfolio with the respective stakeholders from other areas (Care Enablement, Care Delivery etc.) on a regular basis

  • Supporting the preparation and execution of audits and inspections in the Clinical Research department

  • Ensuring timely internal communication of study results and their appropriate use (conferences, publications, clinical evaluations, presentations etc.)

  • Maintaining contact with key opinion leaders and subject matter experts

  • Providing regular training to employees, including those in related specialist departments, and creating relevant SOPs

  • Ensuring the implementation of processes in accordance with the SOPs

Your profile

  • University Degree or equivalent proficiency in a medical/science-related field (e.g., pharmacy / pharmacology, bioscience or other health science). MD or PhD is a plus

  • More than two years of experience in and knowledge of the conduct of clinical trials involving medical devices and medicinal products, regulatory requirements for clinical trials and the subsequent use of clinical data (clinical evaluations, specialist publications, presentations)

  • Several years of project management experience in the field of clinical research

  • Demonstrated knowledge and understanding of the regulatory, ethics and contractual requirements for starting clinical trials in relevant country

  • Experience working with procurement, collaborating with CROs/vendors and experience with flexible resourcing models preferable.

  • High ability to create and maintain good business relationships, ability to work under pressure with multiple internal clients with competing goals

  • Ability to present clear messages accurately in both written and spoken English from complex information/data to all levels in the organization

  • Analytical and conceptual thinking skills — is able to critically evaluate and solve problems, display good judgment, and maintain appropriate levels of independence

  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases

  • Expert fluency in spoken and written English, other languages is advantageous
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Deadline: 06-12-2024

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