Work rate: 100%
Contract type: Temporary
Duration: 12 months
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
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