Clinical Operations Study Country Lead

Clinical Operations Study Country Lead I (COSCL) is the country level operational lead in clinical studies. He/she owns, and is accountable for, the strategic planning, management and performance of their assigned clinical trials, for his/her country(ies), from country allocation until study closure at the Clinical Study Unit (CSU) level including study country timelines, study country budget, and study conduct in accordance with Sanofi Standard Operating Procedures (SOPs) and/or Quality Documents (QD)s and ICH/GCP and regulatory guidelines & directives.

The COSCL I is the key strategic interface, at country level, with internal and external stakeholders to manage operational processes to accelerate trial conduct. Key interfaces for COSCL are:

• Globally: Clinical Operations Study Lead (COSL), Data Management, Vendor Management, Study Medical Manager, Clinical Supply Chain Study Manager, Patient Recruitment and Retention Lead and other Core Study Team members / transversal roles
• Locally: Clinical Research Associate (CRA), Clinical Project Assistant (CPA) Medical Advisor (MDA), Site Engagement Lead (SEL), Start-Up Strategy Manager (SUSM), Medical Science Liaisons (MSL) and other relevant roles.

COSCL I represents their CSU at the Core Study Team meetings.

COSCL I reports to CSU Team Lead or CSU Head in their given CSU country, while working closely functionally with COSL for study topics. While the COSCL may consult COSL or escalate on operational issues that could affect study costs, speed or quality in the CSU, the COSCL is fully accountable to deliver the study as planned in their CSU level.

Main responsibilities include:

1. Set up local study country strategy and lead country start up activities: Develop and initiate early recruitment and retention strategy and associated materials at local level in collaboration with respective colleagues, identify most successful site mapping and set up site engagement strategy aligning with SEL and MDA, organize the local kick off meeting and lead set-up activities to ensure progress according to study timelines with strategic planning.

2. Lead local study management at CSU on execution of clinical studies according to global and local study plan: Fully own the local level performance of the study, ensuring the study is conducted in compliance with planning and agreed timelines. Accounts for the set-up, completion, and adaptations of project management tools at country level (CTMS, Control room…). Drive performance of the study with risk assessment and mitigation strategies, manage sites engagement aligning with SEL (Site Engagement Lead) and MDA (Medical Advisor) regarding site motivation and provide support to site staff and monitoring team in the conduct of clinical trials. COSCL is the member of Core Study Team meetings representing their CSU. In case of discrepancies/gaps on performance, COSCL should proactively escalate, propose and discuss mitigation and contingency strategy with COSL.

3. Owns Study Budget at country/cluster level and ensures optimization and appropriate management of the financial resources: Collaborate with Start-Up Strategy Manager (SUSM) for preparation of Local Study Budget Form (LSBF) ensuring cost optimization and appropriate projection at the beginning of the study. Manages and maintains Country Study Budget during course of study, ensures timely escalation of issues / risks related to the country budget and initiate LSBF updates.

4. Lead effective communication between all local parties involved in the study to align common goals and define best strategies: Be the main link to the local monitoring team in the management of studies. Collaborate with Vendor Functional Line Managers (FLM) to drive quality and study KPIs, Plan / participate in study site engagement activities (i.e. Recruitment Booster calls), Work closely and proactively with MDAs/SELs early on to drive the country strategy, coordinate local study team meeting, Establish collaboration with GBU Medical Affairs regarding trial conduct and medico-marketing activities. Proactively escalate any resource related risks/issues to CSU management and propose and discuss mitigation strategy at CSU level to ensure appropriate resource allocation and optimization for the study.

Maintain Quality and Compliance: Responsible for data quality, patients’ safety and maintain compliance to study metrics for his/her country(ies). Ensure appropriate quality for data collection and queries resolution. Ensure CRA Study Training according to Study Training metrics through FLMs, Collaborate with QL on audit and inspection related activities, Ensure PAI readiness within CTMS, TMF and other systems.

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