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
