Dir Global Site & Study Operations

Career Category

Job 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

Authority​

• Country level oversight and delivery of clinical trials in alignment with Global Study Strategy
• Authority over Country/Hub level trial operations, site monitoring, risk management, resource allocation and stakeholder coordination
• Lead the country site engagement strategy by guiding SEL AD and/or SELs to maintain compliance, foster strong partnerships, and achieve Partner-of-Choice status.

Outputs

• Trial delivery and optimization of all global and local studies run within the country
• Consistent quality in trial operations across studies in country
• Effective leadership and development of a high-performing country team.
• Strong strategic representation of country in global and regional initiatives and stakeholder engagements

Competencies

• Understanding of global/local level regulations and compliance for clinical execution, including concepts related to ethics submissions, study start-up processes, and site inspection readiness at global/regional level
• Big picture, pro-active thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions
• Experience in assessing internal capabilities and identifying key capabilities to build training content, monitoring skill improvement, and drive competency builds across function and within teams
• Experience in delivering portfolio/cross-study level, budgets, timelines, and performance metrics (time, cost, quality) aligned to country/global / functional priorities.
• Drive risk-based quality management adoption and understanding across organization
• Leading expertise in country/global clinical trial processes, operations with strong track record of program delivery​ across a country/regional/global portfolio
• Experience driving and leading organizations through​ cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
• Adept in intra country and/or cross geography, cultural dynamics and running efficient virtual country/global teams - Ability to lead and motivate geographically dispersed teams in an inclusive manner
• Understand country regional trends/global impacting patient enrollment and patient safety compliance
• Experience inassessing internal capabilities and identifying key capabilities to build training content, monitoring skill improvement, and drive competency builds across function and within teams
• Proficient in driving and leading continuous improvement initiatives for team's working practices, ensuring cross-functional adoption of new processes

Minimum Requirements

• Doctorate degree and 4years of clinical execution experience OR
• Master’s degree and 8years of clinical execution experience OR
• Bachelor’s degree and 10years ofclinical execution experience
• In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Requirements

• +10 years work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
• Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials