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Clinical Research Jobs at Amneal

Searching for high-growth Clinical Research Jobs in India’s pharmaceutical industry? Here’s an exciting opening from Amneal for the role of Executive, Clinical Trial Management in Ahmedabad, Gujarat. This opportunity is perfect for candidates looking to build a strong future in global clinical operations, regulatory documentation, and clinical trial coordination. If you are a Life Science graduate with clinical experience, this could be the perfect opportunity for you to enter the rapidly expanding world of international clinical research and drug development.

About the Company

Amneal Pharmaceuticals is a leading pharmaceutical organization focused on developing and delivering high-quality medicines worldwide. The company operates across generics, specialty pharmaceuticals, and innovative drug development programs. Amneal is known for its strong commitment to research, compliance, innovation, and global healthcare advancement.

Job Details:

• Job Title: Executive – Clinical Trial Management
• Location: Ahmedabad
• Employment Type: Full-Time

Overview

The Executive – Clinical Trial Management will support global clinical development programs for New Chemical Entity (NCE) products by providing operational and administrative support across Phase 1–4 clinical trials. The role focuses on clinical documentation management, regulatory coordination, trial tracking, stakeholder communication, and ensuring compliance with ICH-GCP guidelines and global regulatory standards.

Key Responsibilities

• Provide operational and administrative support for global Phase 1–4 clinical trials.
• Maintain Trial Master File (TMF) and ensure quality control and timely filing of essential clinical documents in accordance with ICH-GCP Section 8 requirements.
• Track study milestones, patient recruitment progress, site initiation activities, and study close-out timelines.
• Support protocol amendments, Investigator’s Brochure (IB) updates, and Informed Consent Form (ICF) revisions.
• Assist in preparation of study-related documentation including monitoring plans, training materials, and site manuals.
• Support preparation and submission of regulatory and ethics committee documentation including IND/CTA submissions, amendments, and annual reports.
• Maintain regulatory correspondence records and submission tracking across global regions.
• Coordinate safety reporting documentation related to SUSARs, DSURs, and PSURs.
• Communicate with global clinical sites, Contract Research Organizations (CROs), laboratories, and external vendors.
• Support site feasibility documentation, questionnaire management, and contract tracking activities.
• Assist in vendor oversight documentation for laboratories, imaging vendors, ePRO/eCOA vendors, logistics providers, and central labs.
• Reconcile clinical trial documents, monitoring reports, and data listings.
• Ensure compliance with ICH-GCP, FDA, EMA, CDSCO guidelines, and internal SOPs.
• Participate in audit readiness and inspection support activities including TMF audits and regulatory inspections.
• Collaborate with stakeholders to support implementation of AI/ML initiatives in clinical operations.
• Schedule global meetings, prepare meeting minutes, and track action items.
• Support preparation of clinical program reports and management presentations.
• Maintain clinical project repositories and version-controlled documentation systems.
• Conduct literature reviews and competitive intelligence analysis related to treatment landscapes.

Educational Qualifications

• BSc/MSc in:
  • Life Sciences
  • Biotechnology
  • Clinical Research
  • or related disciplines

Experience Required

2 to 5 years of clinical research or clinical trial management experience.

Technical Skills

• Knowledge of the clinical trial lifecycle and regulatory requirements.
• Familiarity with:
  • Trial Master File (TMF) systems
  • Clinical Trial Management Systems (CTMS)
  • Electronic Data Capture (EDC) platforms
  • Document management systems
• Basic understanding of pharmacovigilance and safety reporting processes.
• Knowledge of AI/ML applications in clinical research environments.
• Proficiency in MS Office and clinical trial software tools.

Core Competencies

• Strong organizational and documentation management skills.
• Excellent communication and stakeholder coordination abilities.
• High attention to detail with a compliance-focused approach.
• Ability to work effectively within global cross-functional teams and across multiple time zones.

APPLY ONLINE HERE