The Clinical Document Specialist plays a critical role in ensuring the completeness, quality, and inspection readiness of the TMF across the clinical portfolio. Operating within the Documentation Management function of CDO Study Management, the Specialist leads TMF oversight activities that directly impact regulatory compliance, audit outcomes, and trial delivery success.
This role is accountable for managing and optimizing TMF operations, including expected document planning, document filing, quality control, archiving and inspection preparation while applying risk-based oversight through metrics, audits, and data-driven insights.. The Specialist collaborates cross-functionally with study teams, vendors and global stakeholders to ensure timely and accurate documentation practices and contributes to the continuous improvement of TMF processes, tools, and standards.
With deep expertise in GCP, regulatory requirements, and eTMF systems, the clinical document specialist influences documentation strategy, supports inspection readiness across programs, and drives operational excellence in clinical documentation management.
The successful candidate will be skilled with:
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Strong expertise in Veeva Clinical Suite and associated processes, with the ability to quickly understand system capabilities and constraints.
Capable of independently taking ownership of defined work packages, ensuring delivery from initiation through to completion.
High level of autonomy, with the ability to work largely independently while maintaining alignment with overall project objectives.
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Awareness of system and process dependencies, particularly with regard to system release cycles, and ability to plan activities accordingly.
- Planned tasks:
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Shift from manual TMF oversight creation to a data-driven, automated oversight model aligned with OMP/Veeva capabilities
Transform Deep Dives from an IR / inspection-driven tool into a continuous performance oversight methodology
Consolidate fragmented support tools into the core system (Veeva Clinical / OMP)
Qualification:
Bachelor's degree in Life Science Qualification
8+ Years of experience in Clinical Operations, eTMF management related activities
1+ year of leadership responsibility . In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Knowledge, Skills and Abilities:
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
• Supports allocation activities per the local resourcing process. Supports activities of project
leads/functional leads to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables.
• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk based monitoring approach.
• Alerts management to quality issues, requests QA audits as appropriate, and supports direct reports and project team in providing audit responses as required.
• Manages and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
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