Project Manager (m/f/d) in Clinical Research

Workplace: 60311, Frankfurt

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What to expect:

The Local Study Manager (LSM) is part of the Clinical Study Unit (CSU) and is accountable for the strategic planning & management and performance of their assigned clinical trials from country allocation within feasibility process until study closure inclusive archiving at the CSU level including study timelines, study budget, and study conduct in accordance with Sanofi SOPs and ICH/GCP and regulatory guidelines & directives. This includes the ability to identify and anticipate risks jeopardizing the trial performance and to develop and initiate countermeasures based on proposer planning and regular revision of the plans. The LSM is working cross-countries or cross-clusters and covers satellite countries as well.
The LSM acts on country/cluster level as the key strategic interface with internal and external stakeholders to develop, implement, maintain, and improve operational processes to accelerate trial conduct in close collaboration with respective functions within CSU and other departments, e.g. Medical Advisor, Site Engagement Manager, Strategic Start Up Manager, Medical Science Liaisons.
The LSM acts as Person of contact within a therapeutic area in terms of study management and conduct and leads a study team through change management efforts and by example. The LSM represents the LSM perspective for CSU in organization wide initiatives.

Bachelor’s degree or higher degree in Health or Natural Sciences or equivalent
3 years of experience in clinical research are mandatory, preferably in combination with experience in project management and certain time as field monitor or site coordinator.
Willing to travel
Proficiency in complex trial management
Broad scientific knowledge within several therapeutic areas
International experience working with teams abroad (regulatory/communication)
Certification level of Project Management (PMP/PMI)
Fluent in English and German

There are many reasons to work at Bertrandt: diverse projects with people, ideas and perspectives. Without a strong team, there is no success.