Senior Clinical Trial Manager

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Guide and coordinate Local Study Teams, comprising CRAs and study support staff, to ensure clinical studies are conducted within established timelines, budgets, and quality benchmarks.

• Supervise country-level study initiation tasks, which include feasibility evaluations, site selection, site qualification, regulatory and ethical submissions, and site activation.

• Oversee the progress of studies at the country level by proactively identifying risks, implementing mitigation strategies, and ensuring the prompt resolution of operational challenges.

• Manage site monitoring activities and provide direction to CRAs to ensure adherence to study protocols, ICH GCP, sponsor requirements, and local regulations.

• Ensure effective management of study budgets, investigator contracts, site payments, study systems, and vendor activities within the country.

• Maintain readiness for inspections through proper oversight of TMF/eTMF documentation, quality management activities, audits, and regulatory inspections.

• Collaborate with global study teams, investigators, vendors, and cross-functional stakeholders to facilitate patient recruitment and the successful execution of studies.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.

• Extensive clinical research experience in roles such as Clinical Research Associate (CRA), Senior CRA, Study Management, or other related Clinical Operations positions.

• In-depth knowledge of ICH GCP, clinical trial regulations, and specific regulatory requirements of the country.

• Demonstrated experience in leading cross-functional teams and managing clinical studies throughout the entire study lifecycle.

• Strong project management, stakeholder management, and risk mitigation abilities with a proven capacity to effectively handle multiple priorities.

• Willingness to travel as necessary (approximately 25%).

• 3 to 5 years of experience in project management.

• Employment is contingent upon possessing the legal right to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career advancement pathways.