Local Study Manager - all genders
Local Study Manager – all genders
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About the job
The Clinical Study Unit (CSU) is a strategic function driving the end-to-end integration of our asset development. CSU acts at forefront to introduce new treatments to scientific and medical community and patients, to be the industry leader in clinical development focused on patient-driven solutions for the future. Our mission is to connect science with business requirements, end-to-end. The CSU works as an innovative and engaged R&D representative in the cluster countries Germany, Austria and Switzerland (GSA). The team is based in Berlin.
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
Responsible for study timelines, study budget, and study conduct in accordance with Sanofi SOPs and ICH/GCP and regulatory guidelines & directives
Identifies and anticipates risks jeopardizing the trial performance, develops and initiates countermeasures based on proposer planning and regular revision of the plans.
Works cross-country 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
Develops, implements, maintains and improves 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).
Acts as person of contact within a therapeutic area in terms of study management, conducts and leads the study team through change management efforts and by example. The LSM represents the LSM perspective for CSU in organization wide initiatives.
Education and professional experience:
Master’s degree or higher degree in Medicine, Pharmacy, Health or Natural Sciences or equivalent
Several years of experience in clinical research is mandatory, preferably in combination with experience in project management and certain time as field monitor or site coordinator
Solid understanding of GCP/ICH phase I-IV clinical trials and observational studies, trial designs, knowledge of pharmaceutical product life-cycle and regulatory requirements
Proficiency in complex trial management, broad scientific knowledge within several therapeutic areas
International experience working with teams abroad (regulatory/communication), strong stakeholder management skills
Problem-solving and risk-management skills
Strong analytical thinking
High willingness to travel within Germany, Switzerland, Austria 2-3 times per month
Certification level of Project Management (PMP/PMI)
Fluent in English and German
Pursue Progress. Discover Extraordinary.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.