Clinical Trial Executive Assistant

Reports To

Clinical Trial Manager / Director of Clinical Operations / Executive Leadership

Job Summary

The Clinical Trial Executive Assistant provides high-level administrative, operational, and coordination support to clinical trial leadership teams and executives involved in clinical research activities. This role ensures efficient management of clinical trial documentation, meetings, communications, travel, vendor coordination, and regulatory tracking while maintaining confidentiality and compliance with applicable regulations and Good Clinical Practice (GCP).

The ideal candidate is highly organized, detail-oriented, proactive, and experienced in supporting fast-paced pharmaceutical, biotechnology, or CRO environments.

Key Responsibilities:

Executive & Administrative Support

• Provide executive-level administrative support to clinical leadership teams.
• Manage calendars, meetings, travel arrangements, and expense reports.
• Coordinate domestic and international travel logistics for study-related activities.
• Prepare meeting agendas, presentations, minutes, and action trackers.
• Organize leadership meetings, investigator meetings, advisory boards, and team workshops.

Clinical Trial Coordination

• Assist in coordinating clinical trial activities across multiple studies and regions.
• Support tracking of study milestones, timelines, and deliverables.
• Maintain study documentation, filing systems, and Trial Master File (TMF) records.
• Coordinate communication between sponsors, CROs, sites, vendors, and internal stakeholders.
• Support onboarding and document collection for investigators and study sites.

Documentation & Compliance

• Ensure proper handling of confidential and regulated clinical documents.
• Assist with preparation and formatting of reports, SOPs, and study-related materials.
• Support inspection readiness activities and audit documentation requests.
• Maintain accurate records in compliance with ICH-GCP, FDA, EMA, and company policies.

Communication & Stakeholder Management

• Serve as a point of contact for clinical teams and external partners.
• Facilitate cross-functional communication between clinical operations, medical affairs, regulatory, and finance teams.
• Draft professional correspondence and meeting summaries.
• Follow up on action items and ensure timely completion.

Financial & Vendor Support

• Track invoices, purchase orders, and vendor payments.
• Assist with contract processing and vendor documentation.
• Support budget tracking and expense reconciliation for study activities.

Data & Systems Management

• Maintain study trackers, dashboards, and databases.
• Support electronic systems such as CTMS, eTMF, SharePoint, Veeva, or other clinical platforms.
• Generate reports and metrics for leadership review.

QualificationsEducation

• Bachelor’s degree in Life Sciences, Business Administration, Healthcare Administration, or related field preferred.

Experience

• 3–5+ years of clinical trial executive assistant or administrative experience in pharmaceutical, biotech, healthcare, or CRO environments.
• Experience supporting clinical trials or clinical operations teams preferred.
• Familiarity with clinical research terminology and processes.
• Experience with writing and submitting reports

Skills & Competencies

• Strong organizational and multitasking abilities.
• Excellent verbal and written communication skills.
• High attention to detail and accuracy.
• Ability to manage confidential information professionally.
• Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Experience with clinical systems (CTMS, eTMF, Veeva, SharePoint) is an asset.
• Ability to work independently and in cross-functional global teams.
• Strong problem-solving and time-management skills.

Preferred Qualifications

• Knowledge of ICH-GCP guidelines and clinical trial processes.
• Experience in global clinical studies.
• Experience supporting senior executives or leadership teams.
• Multilingual skills are an advantage.

Pay: ₹15,000.00 - ₹20,000.00 per month

Benefits:

• Flexible schedule
• Work from home

Work Location: Remote