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

Qualifications

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

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

• 6 years or more in Pharmaceutical/ Regulatory Affairs

• Hands on regulatory experience developing FDA submissions

• Demonstrated knowledge if FDA requirements

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.