Local Study Manager

  • Full time
  • Prague
  • Posted 1 week ago

Sanofi

  • Travel: required / Czech Republic and/or Slovakia
  • Location: Prague
  • Job type: Permanent
  • About the job

    New 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 startup 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.

    Main responsibilities:

  • 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
  • About you

    Requirements:

  • 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
  • Skills (desirable but not essential): Proficiency in complex trial management, broad scientific knowledge within several therapeutic areas, international experience working with teams abroad (regulatory/communication)
  • Education : Bachelor’s degree or higher degree in Health or Natural Sciences
  • Languages : Fluent in English and Czech/Slovak languages
  • Willing to travel
  • Knowledge And Skills Desirable But Not Essential: Proficiency in complex trial management. Knowledge of GCP/ICH phase I-IV clinical trials and observational studies. Scientific knowledge within several therapeutic areas. International experience working with teams abroad. Analytics/ Digital Skills, Lead (small) Teams, Interpersonal & Relationship Management
  • 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.

    Watch our and check out our Diversity Equity and Inclusion actions at !

    #LI-EUR

    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.

    To apply for this job please visit cz.talent.com.