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Local Study Manager

Synthorx

Synthorx

Athens, Greece
Posted on Tuesday, September 5, 2023

Location: Athens (Greece)

50% Remote working, up to 20% travelling

Job type: Permanent, Full time

About the job

Our Team:

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.

Main responsibilities:

  • 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

About you

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

Soft Skills:

  • 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!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.

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.

Pursue Progress. Discover Extraordinary.

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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.