Manager, Clinical Trial Management
Amneal Pharmaceuticals · Posted today
- Ahmedabad, Gujarat, India (On-site)
- Full-time
- 15+ yrs
About the role
Description
JOB DESCRIPTION
The position is responsible for designing, developing, executing, and overseeing registered and non-registered clinical trials for products addressing unmet medical needs and commercial opportunities. The role provides scientific, operational, and regulatory leadership across clinical trial planning, execution, monitoring, data review, and submissions. It ensures accuracy, completeness, and integrity of clinical data at study sites. The role leads risk assessment, budgeting, CRO oversight, audit readiness, and study close-out activities, while ensuring compliance with regulatory guidelines, SOPs, and global clinical standards, thereby enabling reliable clinical outcomes and high-quality regulatory submissions.
Essential Functions
- Lead end-to-end clinical trial management and execution, including registered and non-registered studies
- Design and review clinical protocols, method development, and method validation documents
- Provide scientific oversight for trial eligibility, efficacy, safety, coding, and protocol deviations
- Review and verify bioanalytical data integrity, including raw data, worksheets, and electronic records
- Identify, document, and resolve data discrepancies, errors, and irregularities
- Manage CRO interactions, regulatory queries, audit responses, and study close-out visits
- Ensure compliance with regulatory guidelines, SOPs, and clinical quality standards
- Oversee risk assessment, budgeting, costing, and operational planning for trials
- Prepare and review analytical and clinical study reports for accuracy and completeness
- Maintain comprehensive documentation of data review activities and corrective actions
- Support troubleshooting and continuous improvement across clinical trial operations
- Additional Responsibilities
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience
- 15 years or more in 15+ Years
Specialized Knowledge: Licenses
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
About The Team
The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.