Local Study Manager
Local Study Manager
- Travel: required occasionally - Czech Republic and/or Slovakia
- Location: Prague
- Job type: Permanent
About the job
Clinical Study Unit (CSU) is part of Clinical Operations. CSU constitutes from LSMs, CRAs and supporting functions under supervision of CSU Country Head. The supported team spirit is professional, open-minded, goal-oriented, innovative and collaborative.
New internal opportunity within Sanofi Czech Republic as Local Study Manager (LSM). As Local Study Manager, you will be accountable for the strategic planning & management and performance of the assigned clinical trials from country allocation within start-up process until study closure inclusive archiving, including study timelines, study budget, and study conduct in accordance with Sanofi SOPs and ICH/GCP and regulatory guidelines & directives.
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 clinical and other departments.
- Early participation to address operational aspects in the study country strategy in partnership with relevant parties to ensure a smooth and fast achievement of the First Patient In, including but not limited to Feasibility process; Identification of potential gaps; Assessment for initiation risks (processes/vendors/site performance); Review and approval for the site selection reports and definition of sites selected for the study to Cluster/CSU Head for final approval; Development of early recruitment and retention strategy
- Lead local study management at the country level from operational point of view since feasibility process, through study conduct to the end of the study, including but not limited to Leading the set-up activities at country level; Oversight of performance of the study: drive risk assessment and develop contingency planning and risk-mitigation strategies at country level if needed; activities for site engagement regarding site motivation and performance; Participation in site initiations as needed; Support to site staff and monitoring team in the conduct of clinical trials
- Oversee Study Budget at country/cluster level and ensures optimization and appropriate management of the financial resources
- Promote effective communication between all parties involved in the study to align common goals and define effective strategies, including but not limited to Be the main link to the local monitoring team in the management of studies and coordinate local study meetings; Collaborate with Vendor Functional Line Managers to drive quality and study KPIs
- Maintain Quality and Compliance through vendor oversight of all project deliverables according to project timelines and KPIs, including but not limited to e responsible for data quality (data collection and queries resolution), for Patients’ safety and compliance to study metrics; to Ensure proper mitigation plans are in place for noted risk; Monitoring Visit Report Review; Ensure Local study team Study Training; Collaborate with Quality Lead on audit and inspection related activities
- Experience: 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
- Knowledge and skills desirable but not essential: Proficiency in complex trial management, knowledge of GCP/ICH phase I-IV clinical trials and observational studies, broad scientific knowledge within several therapeutic areas, international experience working with teams abroad (regulatory/communication), Analytics/Digital Skills, Lead (small) Teams, Interpersonal & Relationship Management
- Education: Bachelor’s degree or higher degree in Health or Natural Sciences
- Languages: Fluent in English and Czech languages (Slovak accepted as well)
- Willing to travel
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