Website:
sotalent.us
Job details:
Senior Manager – Clinical Operations
Location: Mumbai, India
Industry: Pharmaceuticals | Clinical Research | Life Sciences
About the Role
An opportunity is available for an experienced Senior Clinical Operations Manager to oversee clinical trial operations, lead research teams, and ensure the successful execution of clinical studies within a global pharmaceutical environment.
The role involves managing clinical operations personnel, overseeing study performance, ensuring regulatory compliance, and collaborating with internal and external stakeholders.
Key Responsibilities
- Lead and supervise clinical operations teams, including Clinical Trial Managers, Monitors, Associates, and Study Start-up Specialists.
- Oversee country-level clinical trial execution, timelines, quality, and performance.
- Manage resource allocation, workload planning, and operational priorities.
- Monitor clinical study KPIs and implement performance improvements.
- Ensure compliance with ICH-GCP, local regulations, and clinical research standards.
- Support regulatory inspections, audits, and Corrective and Preventive Action (CAPA) processes.
- Manage recruitment, performance reviews, and development of clinical operations staff.
- Collaborate with Medical, Regulatory, Pharmacovigilance, Commercial, and other cross-functional teams.
- Maintain relationships with investigators, clinical trial sites, research partners, and health authorities.
- Support clinical research strategy, operational planning, and continuous improvement initiatives.
Required Qualifications & Experience
- Bachelor's degree, preferably in Life Sciences or a related discipline, or equivalent qualification.
- 12–15 years of experience in Clinical Operations.
- In-depth knowledge of ICH-GCP guidelines, clinical research regulations, and trial management processes.
- Strong understanding of clinical study execution, monitoring, and regulatory compliance.
- Proven leadership, team management, and resource planning abilities.
- Excellent stakeholder management, communication, and problem-solving skills.
- Ability to manage competing priorities and make independent operational decisions.
Additional Information
Location: Mumbai, India
Sector: Pharmaceutical Research & Development
The specific working arrangement, salary, and benefits have not been disclosed in the available job description.
Equal opportunity employment practices apply.
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