PHARMAFull-time
Clinical Document Specialist
By Admin · Clinical Research & Clinical Operations
UNKNOWN (IN)ONSITEPOSTED: 8/26/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
The Clinical Document Specialist operates within the Documentation Management function of CDO Study Management and plays a critical role in ensuring completeness, quality, compliance, and inspection readiness of the Trial Master File (TMF) across the clinical portfolio. The position supports the PPD clinical research portfolio and contributes directly to regulatory compliance, audit readiness, clinical-trial delivery, and operational excellence.
Core Responsibilities
Manage and optimize TMF operations across the clinical portfolio.
Oversee expected document planning, document filing, quality control, archiving, and inspection preparation.
Apply risk-based oversight using metrics, audits, and data-driven insights.
Collaborate with study teams, vendors, Process Owners, and global stakeholders to ensure timely and accurate documentation.
Contribute to continuous improvement of TMF processes, tools, and documentation standards.
Support documentation strategy and inspection readiness across clinical programs.
Drive operational excellence in clinical documentation management.
TMF & Clinical Documentation Expertise
Ensure TMF completeness and quality throughout the clinical portfolio.
Maintain documentation in an inspection-ready state.
Support regulatory compliance and audit outcomes through effective document-management practices.
Apply knowledge of GCP and regulatory requirements to clinical documentation activities.
Work with eTMF systems and associated clinical documentation processes.
Technology & Data Transformation
Demonstrate strong expertise in Veeva Clinical Suite and associated processes.
Understand system capabilities, constraints, and process dependencies.
Transition TMF oversight from manual creation toward a data-driven and automated oversight model aligned with OMP/Veeva capabilities.
Transform Deep Dives from an inspection-driven tool into a continuous performance-oversight methodology.
Consolidate fragmented support tools into core systems such as Veeva Clinical and OMP.
Plan activities around system release cycles and related dependencies.
Project & Work Package Ownership
Independently own defined work packages from initiation through completion.
Operate with a high level of autonomy while remaining aligned with project objectives.
Engage stakeholders proactively, including Process Owners and other key partners.
Follow a structured Plan–Do–Check working approach.
Plan and manage activities.
Monitor progress against timelines.
Deliver high-quality outputs including guidance documents, concepts, and frameworks.
Leadership & Clinical Operations Support
Possess at least one year of leadership responsibility.
Manage and conduct induction/orientation programs for new employees.
Support local resourcing and allocation activities.
Support project leads and functional leads in optimizing operational project execution.
Escalate issues that may affect project deliverables.
Deliver training on Working Practice Documents (WPDs), Standard Operating Procedures (SOPs), local requirements, and other clinical-operations topics.
Identify training gaps and ensure training requirements are addressed.
Contribute to development of training programs when appropriate.
Quality, Risk & Compliance
Participate in process-improvement and process-development initiatives.
Support understanding and facilitation of risk-based monitoring approaches.
Alert management to quality issues.
Request QA audits when appropriate.
Support direct reports and project teams in preparing audit responses.
Maintain strong awareness of GCP, regulatory expectations, quality requirements, and inspection readiness.
Systems, Metrics & KPIs
Manage and review clinical systems including CTMS, Preclarus, and Clarity.
Evaluate employee and project metrics, KPIs, and overall project status.
Use operational data and performance insights to support oversight and decision-making.
Qualification & Experience
Bachelor's degree in Life Sciences or equivalent qualification.
8+ years of experience in Clinical Operations and eTMF-management-related activities.
1+ year of leadership responsibility.
Equivalent combinations of education, training, and directly related experience may be considered where applicable.
Work Environment
Work schedule: Standard, Monday-Friday.
Environmental condition: Office.
REQUIRED VERIFIED SKILLS
Clinical Operations
eTMF Management
TMF Management
Veeva Clinical Suite
Clinical Documentation Management
GCP
Regulatory Requirements
Inspection Readiness
Document Planning
Document Filing
Document Quality Control
Document Archiving
Risk-Based Oversight
Data-Driven Oversight
Clinical Trial Documentation
CTMS
Preclarus
Clarity
KPI Management
Quality Management
QA Audits
Risk-Based Monitoring
SOPs
WPDs
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global leader in serving science, providing an extensive range of analytical instruments, laboratory equipment, reagents, consumables, software, and services. They partner with pharmaceutical and biotech companies, hospitals, clinical diagnostic labs, universities, research institutions, and government agencies. The company's mission is to enable its customers to make the world healthier, cleaner, and safer.
TEAM SIZE: 130,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
RECOMMENDED TRAINING
1/5
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