This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Operations Lead (Clinical Trial Manager) based in India.
This role offers the opportunity to lead clinical trial operations and support the successful delivery of global research programs.
You will oversee clinical teams, investigator sites, and study activities while ensuring compliance with GCP standards and regulatory requirements.
The position combines clinical operations leadership, project oversight, stakeholder management, and strategic execution.
You will act as a key connection point between clinical research associates, project teams, sponsors, and external partners.
This role is ideal for an experienced clinical research professional who enjoys improving processes, mentoring teams, and driving high-quality study outcomes.
You will contribute to advancing clinical research through effective planning, collaboration, and operational excellence in a remote environment.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Operations Lead (Clinical Trial Manager) based in India.
This role offers the opportunity to lead clinical trial operations and support the successful delivery of global research programs.
You will oversee clinical teams, investigator sites, and study activities while ensuring compliance with GCP standards and regulatory requirements.
The position combines clinical operations leadership, project oversight, stakeholder management, and strategic execution.
You will act as a key connection point between clinical research associates, project teams, sponsors, and external partners.
This role is ideal for an experienced clinical research professional who enjoys improving processes, mentoring teams, and driving high-quality study outcomes.
You will contribute to advancing clinical research through effective planning, collaboration, and operational excellence in a remote environment.
Accountabilities:
- Provide operational oversight of assigned clinical research associates (CRAs) and investigator sites to ensure compliance with study protocols, monitoring plans, ICH-GCP guidelines, and local regulations.
- Support project delivery by monitoring site performance, recruitment progress, data collection, documentation completion, and overall study timelines.
- Conduct co-monitoring and assessment visits to support CRA performance, site management, and compliance with study requirements.
- Review monitoring visit reports, protocol deviations, corrective actions, and quality metrics to ensure high-quality clinical operations.
- Support site feasibility, startup activities, enrollment strategies, and recruitment planning in collaboration with clinical project teams.
- Develop and deliver study-specific training materials, tools, and guidance for CRAs and investigator sites.
- Serve as the primary operational contact for regional CRAs, providing support, mentoring, and escalation management for study-related questions and challenges.
- Conduct regular meetings with clinical monitoring teams and provide updates to project stakeholders regarding country and site performance.
- Collaborate with sponsors and internal teams to provide study status updates and ensure alignment on operational objectives.
- Support vendor management activities and contribute to financial processes related to site payments, revenue recognition, and project expenses.
- Assist with investigator site oversight and CRA responsibilities when required.
- Prepare and present materials for sponsor meetings, investigator meetings, site qualification visits, and site initiation activities.
- College diploma/degree with 7–9 years of related experience and ongoing professional development, or a bachelor’s degree with 4–6 years of relevant experience and continued training.
- Background in Health Sciences, Life Sciences, Nursing, or a related field preferred.
- SoCRA and/or ACRP certification or designation is an advantage.
- Minimum 3 years of experience as a Clinical Research Associate (CRA).
- Strong experience with clinical trial management processes, monitoring activities, and EDC systems.
- Solid understanding of GCP principles, ICH guidelines, local regulations, IRB/EC requirements, and investigator responsibilities.
- Proficiency with Microsoft Office tools and clinical documentation systems.
- Strong report writing skills and ability to critically review clinical research documents.
- Excellent written and verbal communication skills with strong stakeholder management abilities.
- Highly organized, detail-oriented, proactive, and capable of managing multiple priorities in a deadline-driven environment.
- Ability to mentor and support clinical teams while working effectively with global and cross-functional stakeholders.
- Strong problem-solving skills and ability to identify issues, recommend solutions, and drive corrective actions.
- Fully remote, home-based work opportunity in India.
- Opportunity to contribute to global clinical research programs and healthcare advancements.
- Work with experienced clinical operations professionals across international teams.
- Professional growth opportunities through continuous learning and development.
- Exposure to complex clinical trial environments and global research standards.
- Opportunity to make a meaningful impact through high-quality clinical study delivery.
The Clinical Operations Lead will oversee clinical trial execution at regional and global levels, ensuring study deliverables are achieved according to protocols, timelines, quality standards, and regulatory requirements.
Requirements:
The ideal candidate is an experienced clinical research professional with strong knowledge of clinical monitoring, regulatory compliance, and study management processes.