Local Study Manager
Location: Athens (Greece)
50% Remote working, up to 20% travelling
Job type: Permanent, Full time
About the job
As CSU Local Study Manager, you will be accountable for the strategic planning & management and performance of the 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.
You will act on country 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 Partnership Manager, Strategic Start Up Manager, Medical Science Liaisons.
- Early participation to address operational aspects in the study country strategy in partnership with relevant parties to ensure a smooth and fast path to the First Patient in leading Country Study Set up, site selection, patient recruitment and retention strategy
- Lead local study management at the country level from operational point of view starting with experience sharing during feasibility process, through end of the study according to global and local study plan
- Align with Site Partnership Manager (SPM) on activities to engage with sites: calls & meetings for site engagement regarding site motivation and performance or other study related topics, Participate in SIVs as needed
- Oversees Country Supplies Strategy and Planning including assessment and mitigation of local risks
- Oversee Study Budget and ensure 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
- Act as Point 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.
- Maintain Quality and Compliance through vendor oversight of all project deliverables according to project timelines and KPIs
Education: Bachelor’s degree or Advanced degree (MD, PharmD, PhD) in Health, Life or Natural Sciences or equivalent)
Experience: At least 3 years of experience in Clinical Research/Studies, preferably in combination with experience in project management and certain time as field monitor
Knowledge and technical skills:
- Knowledge of GCP/ICH phase I-IV clinical trials, and observational studies
- Risk Management and Project Management Skills
- Trained for Compliance and Business Integrity
- Data Analytics (& Digital) skills
Languages: Oral and written fluency in English, Greek is a must
- Advanced problem-solving skills and business acumen
- Change management ability
- Advanced interpersonal & relationship management skills
What we offer
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An attractive, market-oriented salary aligned with your qualifications
- Company car
- An individual and well-structured introduction and training of new employees
- Professional career opportunities in dynamically developing working environments
- As a globally successful and constantly growing company, Sanofi provides international career paths as well
If the description fits your experience and has captured your interest, please apply so we can get in contact with you!
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