Executive, Clinical Trial Management (Amneal)

Roles and Responsibilities

Key Responsibilities

• Provide administrative and operational support for global Phase 1–4 clinical trials for NCE products.

• Maintain Trial Master File (TMF) and ensure timely filing and quality control of essential documents (ICH-GCP Section 8).

• Track study milestones, study trackers, site initiation, patient recruitment progress, and study close-out activities.

• Support protocol amendments, Investigator’s Brochure (IB) updates, and Informed Consent Form (ICF) revisions.

• Assist in preparation of study-related documents including monitoring plans, site manuals, and training materials.

• Support preparation and submission of regulatory and ethics committee packages (IND/CTA submissions, amendments, annual reports).

• Maintain regulatory correspondence and submission trackers across regions.

• Support safety reporting documentation coordination (SUSARs, DSURs, PSURs).

• Coordinate communication with global clinical sites, CROs, laboratories, and vendors.

• Assist with site selection documentation, feasibility questionnaires, and site contracts documentation tracking.

• Assist in reconciliation of clinical trial documents, data listings, and monitoring reports.

• Ensure compliance with ICH-GCP, regulatory guidelines (FDA, EMA, CDSCO), and internal SOPs.

• Participate in audit and inspection readiness activities (TMF audits, vendor audits, regulatory inspections).

• Collaborate with internal and external stakeholders to implement AI/ML in the department.

• Schedule global team meetings, prepare meeting minutes, and track action items.

• Support preparation of clinical program reports and management presentations.

• Maintain clinical project documentation repositories and version control.

• Literature review, compilation, and presentation

Skills & Competencies

Technical Skills

• Knowledge of clinical trial lifecycle and regulatory requirements – Preferred

• Basic understanding of Clinical Trial workflow

• Familiarity with TMF systems, CTMS, EDC, and document management platforms

• Basic understanding of pharmacovigilance and safety reporting

Soft Skills

• Strong organizational and documentation skills

• Excellent communication and stakeholder coordination abilities

• Attention to detail and compliance mindset

• Ability to work in global cross-functional teams and across time zones 

• Qualifications & Experience

  • Pharm.D or M.Pharm in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field.

  • Freshers with enthusiasm of entering clinical field