Description
Accountabilities
•The Country Study and Site Operations Head is accountable to drive all country and hub & spoke execution and quality measures, including study operations, site operations, and site engagement, while ensuring operational capabilities support the delivery of the geographic portfolio with high-quality data in compliance with local regulations.
•Ensure study execution aligns with global strategies across trials and act as a key advisor for country commitments.
•Provide leadership and line management to the Country/Hub team, offering clear guidance, fostering capability development, and driving portfolio objectives.
•Represent the country strategically in organizational initiatives at all levels.
•Lead the Country Management Team (CMT).
. Ensure Adequate resourcing
**Responsibilities**
**•** **Accountable for all study execution in assigned geography and quality metrics including delivering study start-up, patient enrollment, retention trends, and data flow metrics in alignment with global strategies across trials, serving as key advisor for country commitments**
**•** **Oversee clinical study budgets and forecasting to ensure efficient use of resources and financial accountability.**
**•** **Build, lead, and develop the Country/Hub team to effectively manage resources, ensuring appropriately skilled and high-performing staff to deliver the portfolio and meet organizational deliverables.**
**•** **Drive country site engagement by leading SEL AD and/or SELs, aligning with global strategy, ensuring compliance, strengthening partnerships, and securing Partner-of-Choice positioning through innovation and leadership collaboration.”**
**•** **Shape and foster collaboration between local functional teams and global study teams to drive delivery of study portfolio in assigned geography**
**•** **Partner with internal stakeholders to monitor study progress and drive local actions plan & issue resolution, and aggregates country progress and challenges for senior management**
**•** **Represent country in governance meetings, communicating cross-study progress to region / CPSO**
**•** **Advocate for study placement in considerations of strengths and growth opportunities of assigned geography**
**•** **Lead internal and external meetings to ensure delivery on portfolio targets**
**•** **Key advisor for site selection, and identifies & communicates priority sites, allocating resources as required**
**•** **Point of escalation to support resolution of country-wide issues including risks which impact delivery or quality of clinical trials and/ patient safety**
**•** **Lead country-level risk assessments and implement mitigation strategies to ensure patient safety, compliance, and trial continuity**
**•** **Oversees vendor selection, setup, performance oversight across local roles (study delivery, monitoring) in alignment with budget considerations and serves as point-of-escalation**
**•** **Promote continuous improvement and best practice sharing to enhance operational efficiency and site engagement.**
**•** **Build and develop strong local leadership and study teams to deliver on portfolio goals and support long-term organizational capability**
**•** **Ensures adherence to key requirements (e.g., ICH-GCP, SOP, country regulations), study inspection readiness, internal audits and CAPA processes**
**•** **Work with SDRM to ensure timely and adequately resourcing for all roles**
**•**
