Sr Executive Asst Manager - Clinical Trials Management

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Clinical Research professional to lead scientific reviews, oversee SIV activities with CROs, and ensure regulatory compliance across study documentation. The role involves monitoring patient recruitment, data across sites, and close collaboration with CRO teams to resolve queries during the study lifecycle.

The candidate will review eCRFs, oversee PK/CEP studies for USFDA/EU/Canada, and contribute to the Clinical Study Report reviews.

Qualifications

• M. Pharm (Clinical Pharmacy/Pharmacology) required.
• 5-7 years' experience in clinical research/monitoring preferred.

Responsibilities

• Perform scientific review of Protocol and related documents per regulatory requirements.
• Review SIV presentations prepared by CRO for protocol/regulatory compliance.
• Assess eCRF edits; knowledge of various EDC platforms.
• Accompany CRO personnel for SIV and resolve queries for smooth study execution.
• Track patient recruitment and push CRO for timely delivery.
• Oversee study data across all sites during monitoring.
• Resolve issues identified during monitoring after CRO discussion.
• Track CRO payments per milestone in the agreement.
• Accompany CRO for closeout visit and resolve outstanding queries.
• Handle patient PK and CEP studies for regulated markets (USFDA, EU, Canada).
• Conduct scientific review of Clinical Study Reports.

Skills

SIV coordination

EDC platforms knowledge

Regulatory compliance

Clinical study review

Education

M. Pharm (Clinical Pharmacy/Pharmacology)

Job description

Job Description

• Scientific review of Protocol and related documents i.e ICF, CRF, Plans, logs and forms, etc. as per regulatory requirements.
• Review of SIV presentations prepared by CRO and check for its compliance with protocol and applicable regulatory requirements.
• Should have knowledge of various EDC platforms and can do review of eCRF for edit checks.
• Accompany CRO personnel for SIV and resolve all queries raised during SIV for smooth execution of the study.
• Tracking patient recruitment and pushing the CRO for timely delivery of the project.
• Oversight monitoring of the study data across all sites.
• Resolved all issues identified during the monitoring visit after discussion with CRO to best of interest of the study.
• Track and process on CRO’s payment as per defined milestone in agreement.
• Accompany CRO personnel for closeout visit and resolve all outstanding queries raised during monitoring visit.
• Should have experience in handling patient PK and CEP study for regulated market i.e USFDA, EU, Canada
• Scientific review of Clinical Study Report.

Qualifications

• M. Pharm (Clinical Pharmacy/Pharmacology)
• 5-7 years' Experience

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.