Senior Specialist, Study Training Compliance & DoA Matrix Management

Senior Specialist, Study Training Compliance & DoA Matrix Management

This role offers an opportunity to strengthen training compliance and documentation quality across a portfolio of clinical research studies in a regulated, fast-paced environment. As a key contributor to clinical operations, you will coordinate study training requirements, oversee Delegation of Authority (DoA) matrix management, and help ensure study teams are prepared for activation and ongoing execution. You will collaborate with internal stakeholders, site staff, sponsors, and vendors to maintain accurate, complete, and audit-ready records.

By identifying documentation gaps and improving compliance workflows, you will support operational consistency and adherence to regulatory standards. This fully remote position is suited to an experienced clinical research professional who combines strong organizational skills with attention to detail and a proactive approach to problem-solving.

Accountabilities:

• Monitor and coordinate training completion across multiple clinical studies, ensuring compliance with study-specific requirements, ICH-GCP, standard operating procedures (SOPs), and sponsor documentation standards.
• Verify training accuracy and suitability for assigned roles during study start-up, transitions, and other key study milestones.
• Maintain complete, accurate, and up-to-date training records and certificates within electronic Investigator Site File (eISF) platforms and other internal systems.
• Coordinate the creation, review, approval, and ongoing updates of Delegation of Authority (DoA) matrices in line with protocol requirements and study timelines.
• Confirm that training status and staff roles align with delegated study responsibilities, identifying and escalating gaps before study activation.
• Support audit readiness by preparing documentation, responding to document requests, and assisting with internal audits, sponsor inspections, and monitoring visits.
• Serve as a point of contact for training compliance and delegation documentation questions, providing guidance to internal teams and site staff on requirements and deadlines.
• Partner with clinical operations teams, sponsors, vendors, and other stakeholders to coordinate compliance activities and resolve documentation challenges.
• Contribute to study-specific training plans, compliance trackers, and standardized tools that improve visibility, consistency, and operational efficiency.
• Identify process improvement opportunities and assist in developing and refining guidance materials, trackers, and internal SOPs.
• Participate in meetings, share subject matter expertise, and perform additional duties as assigned.

• Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred.
• Three to five years of experience in central support, clinical operations, clinical research compliance, or a related function, ideally within a regulated research environment.
• Demonstrated experience supporting or leading training compliance workflows, DoA matrix coordination, and documentation management across multiple clinical studies.
• Strong understanding of clinical research operations, training documentation, regulatory requirements, and quality-driven processes.
• Familiarity with ICH-GCP principles, SOPs, sponsor requirements, and maintaining audit-ready documentation across clinical trials.
• Experience with electronic Investigator Site File (eISF) platforms, particularly Florence, Clinical Trial Management Systems (CTMS), Clinical Conductor, sponsor portals, and other training or compliance systems is strongly preferred.
• Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and SharePoint, as well as compliance tracking…