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

📌 Manager, Clinical Trial Management (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad