Senior Executive, Clinical Affairs

The Senior CRA will provide operational and administrative support to global clinical trial teams involved in New Chemical Entity (NCE) development programs. The role involves coordination of clinical trial documentation, regulatory submissions, site and vendor communications, trial tracking, and support to global clinical operations teams to ensure studies are conducted in compliance with ICH-GCP, global regulatory requirements, and internal SOPs.

The Clinical Operations Assistant will also support digital and AI/ML-enabled clinical trial activities, including data management workflows, trial tracking dashboards, and AI-assisted trial operations tools.

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.

· Support vendor oversight documentation (laboratories, imaging vendors, ePRO/eCOA vendors, central labs, logistics providers).

· 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.

Skills & Competencies

Technical Skills

· Knowledge of clinical trial lifecycle and regulatory requirements

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

· Basic understanding of pharmacovigilance and safety reporting

· Basic understanding of AI/ML concepts in clinical research

· Proficiency in MS Office and clinical trial software tools

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

Education:

• Master Degree (MS/MA) Science Field - Preferred

• Bachelors Degree (BA/BS) Science Field - Required

Experience:

• 6 years or more in Pharmaceutical/ Regulatory Affairs

Specialized Knowledge:

• Hands on regulatory experience developing FDA submissions

• Demonstrated knowledge if FDA requirements

Licenses: 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.