Supervisor, CPS Document Specialist – Remote | Full-Time | Bangalore / Remote India
Location: Bangalore or Remote (India)
Job Type: Full-Time
Department: Clinical Project Services (CPS) / Clinical Document Management
Experience Required: Minimum 5+ years in TMF-focused leadership or management role
Job Overview
We are seeking an experienced Supervisor, CPS Document Specialist to lead and oversee Trial Master File (TMF) operations within a global clinical research environment. This role is responsible for supervising Document Specialists, ensuring TMF compliance, driving inspection readiness, and maintaining document quality in alignment with regulatory standards, sponsor expectations, and project timelines.
The ideal candidate brings strong leadership capabilities, deep expertise in electronic Trial Master File (eTMF) systems, audit readiness, and clinical document management processes within a CRO or pharmaceutical setting. This position plays a critical role in ensuring data integrity, operational efficiency, and regulatory compliance across assigned clinical programs.
This is a remote-based position in India with standard business collaboration requirements.
Key Responsibilities
Team Leadership & Supervision
Provide line management and oversight for Document Specialists, including recruitment, onboarding, training, performance evaluation, development planning, and disciplinary actions where necessary.
Develop, review, and update training materials for Document Specialists and deliver training sessions on TMF systems and processes.
Build strong support networks to enhance team productivity, utilization, and professional growth.
Trial Master File (TMF) Management & Compliance
Oversee organization, collection, scanning, filing, and maintenance of clinical documents in electronic and/or paper-based TMF systems in accordance with SOPs and regulatory standards.
Ensure timely and accurate filing for CPS Project Managers, Clinical Monitoring Teams, internal stakeholders, and external sites.
Take ownership of assigned TMFs across Fortrea and client systems, ensuring milestone adherence and documentation completeness.
Assist in the development and finalization of TMF Plans, Indexes, and Expected Document Lists.
Quality Control & Inspection Readiness
Generate document queries and conduct reconciliation activities to ensure TMF completeness, accuracy, and audit readiness.
Lead resolution of QA findings and sponsor audit observations related to TMF documentation.
Proactively support inspection readiness initiatives and implement corrective and preventive actions where required.
Perform document quality checks and follow up with project teams on missing or incomplete documentation.
Stakeholder & Client Engagement
Serve as TMF Subject Matter Expert and primary point of contact for TMF-related client and internal inquiries.
Participate in RFI/RFP submissions and support bid defense meetings when required.
Collaborate with Project Managers, Project Coordinators, and cross-functional teams to ensure TMF reconciliation and compliance.
Represent CPS interests in SOP development, business process optimization, and system improvements.
Operational Excellence & Continuous Improvement
Drive TMF optimization initiatives through continuous process improvements.
Maintain tracking tools, spreadsheets, and documentation logs to monitor compliance and productivity metrics.
Demonstrate financial awareness and understand the operational cost impact of decision-making.
Support departmental administrative and reporting activities as required.
Required Qualifications
High School Diploma or equivalent (minimum requirement).
Bachelor’s degree in a scientific field preferred; relevant experience may substitute for formal education.
Fluency in English (written and verbal).
Experience Requirements
Minimum 5 years of experience in a TMF-focused leadership or management role within clinical research.
Strong working knowledge of eTMF systems, document control processes, and regulatory inspection requirements.
Proven experience in supervising teams, conducting performance reviews, and leading training initiatives.
Experience managing document reconciliation, audit readiness, and quality assurance processes.
Proficiency in Adobe Acrobat, Microsoft Word, Excel, and PowerPoint.
Demonstrated ability to manage multiple projects simultaneously in a fast-paced environment.
Preferred Qualifications
Bachelor’s degree in Life Sciences or related scientific discipline.
Experience within a CRO or pharmaceutical clinical operations environment.
Prior involvement in sponsor audits, regulatory inspections, or bid defense presentations.
Work Environment & Physical Requirements
Remote or standard office-based working environment.
Extended computer usage up to 8 hours per day.
Potential requirement to work outside normal office hours based on project demands.
Risk of repetitive strain or eye strain associated with prolonged screen time.
Why Apply Through ThePharmaDaily
This leadership opportunity is ideal for professionals specializing in Clinical Document Management, Trial Master File operations, eTMF systems, regulatory compliance, and audit readiness within global clinical trials.
If you are an experienced TMF leader with strong supervisory skills and a commitment to quality and inspection readiness, apply now to advance your career in clinical project services and regulatory documentation excellence.
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