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Senior Clinical Project Manager

vor 2 Monaten


Frankfurt, Deutschland APRIORI - business solutions AG Vollzeit

Are you ready to take on a new challenge in the dynamic world of clinical research? If you are passionate about driving impactful clinical trials, have a keen eye for strategic planning, and thrive in an international environment, then this opportunity is perfect for you Our client, a leading global pharmaceutical company in Frankfurt/Main, is looking for an experienced and motivated Project Manager in Clinical Research to lead and oversee the successful execution of clinical trials. Join a team where your expertise will shape the future of healthcare.


Purpose:

  • The Local Study Manager (LSM) is an integral part of the Clinical Study Unit (CSU) and is responsible for the strategic planning, management, and performance of assigned clinical trials from the country allocation within the feasibility process to study closure, including archiving at the CSU level. This encompasses managing study timelines, budget, and ensuring the study is conducted in compliance with company SOPs, ICH/GCP, and regulatory guidelines.
  • The LSM identifies potential risks that could impact the trial's performance and proactively develops and implements countermeasures. They regularly review and adjust plans to ensure the trial stays on track. The role may involve cross-country or cross-cluster responsibilities, including oversight of satellite countries.
  • The LSM serves as a key strategic interface at the country/cluster level, liaising with both internal and external stakeholders. They play a pivotal role in developing, implementing, and improving operational processes to accelerate trial conduct. This requires close collaboration with various functions within the CSU and other departments, such as Medical Advisors, Site Engagement Managers, Strategic Start-Up Managers, and Medical Science Liaisons.
  • As the point of contact within a therapeutic area for study management and conduct, the LSM leads a study team through change management initiatives and by example. They represent the LSM perspective in organization-wide initiatives within the CSU.´


Required Qualifications:

  • A Bachelor’s degree or higher in Health or Natural Sciences or an equivalent qualification.
  • A minimum of 3 years of experience in clinical research, with a strong preference for candidates who also have experience in project management and have spent time as a field monitor or site coordinator.
  • Willingness to travel as needed.
  • Proficiency in managing complex clinical trials.
  • Broad scientific knowledge across various therapeutic areas.
  • International experience working with teams in different countries, particularly in regulatory or communication roles.
  • Project Management certification (e.g., PMP/PMI) is required.
  • Fluent in English.