Summary

The Senior Clinical Trial Assistant (Sr. CTA) provides high-quality operational and administrative support to clinical trial teams throughout all phases of a pharmaceutical study. Operating within a fast-paced, regulated environment, the Sr. CTA ensures clinical documentation is accurately maintained, processes are followed, and systems are updated in a timely and compliant manner. This position works cross-functionally with internal stakeholders and external partners (e.g., CROs, vendors, investigator sites) to enable successful study execution in line with relevant pharmaceutical standards.

Responsibilities

• Support the Clinical Project Manager(s) in study execution, including tracking study milestones and key deliverables
• Maintain and manage the Trial Master File (TMF/eTMF), performing periodic completeness and quality reviews
• Assist in preparation, review, finalization, and distribution of study documents
• Participate in study team meetings, take minutes, and track follow-up actions, decisions, risks to resolution
• Support coordination of investigator payments and third-party vendor payments as needed
• Contribute to contract and budget tracking under supervision of CPM
• Create and maintain trackers, tools, and reports to monitor study metrics and document flow
• Assist in training record tracking for study teams and site personnel
• Engage with internal and external stakeholders (e.g., CROs, vendors, sites) professionally and proactively
• Participate in department-wide process improvement or documentation initiatives

Qualifications

• BSc/BA degree in health care, life sciences or related field
• Minimum of 4 years’ experience as a CTA in a pharmaceutical, CRO, or biotech environment in the context of pharmaceutical clinical trials
• Familiarity with ICH-GCP, clinical trial life cycle, and document control and retention practices
• Prior experience working in an outsourced study model or supporting vendor oversight preferred
• Experience using electronic TMF systems and understanding of TMF Reference Model
• Fluency in spoken and written English
• Stakeholder management and communication skills

Personal Qualities

• Excellent verbal and written communication skills
• Attention to detail and ability to manage multiple priorities independently
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)
• Solution-oriented mindset and proactive working style
• Strong documentation and record-keeping abilities
• Willingness to travel as required for business needs