Centralized Study Specialist II (eTMF)

Job Location(s) IN-Bangalore
Job Number
Job Category
Client Services
Position Type

Job Overview

Only Bangalore, India location.
- Follow all applicable departmental Standard Operating Procedures and Work Instructions.
- Complete required trainings according to required timelines.
- Complete day-to-day tasks ensuring quality and productivity.
- File review and Inspection readiness experience is important. 
- Manage project and technical documentation in an appropriate manner.
- Provide administrative and technical support to internal departments and teams as needed.
- Perform checks to ensure quality of work completed.
- Ensure timely escalation and issue resolution as needed.
- Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
- Support implementation of new monitoring tools
- Ability to work on Multiple studies and prioritize depending on conflicts
- Track and report metrics as determined by management according to required timelines.
- Proactively identify opportunities for process improvements and lead the implementation of process improvement activities to enhance deliverables.
- Support the implementation of tools internally to enhance deliverables
- Able to mentor and train others
- Work with Global Stakeholders
- Assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
- Assist in the preparation of new investigator submission packages for site/regulatory submission.
- Support study team for contracts and budgets activities for investigative sites including but not limited to Investigatory Payment, Pass through payment processing & tracking
- Assist the study start up teams with tasks required for site start up activities. 
- Review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines
- Other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems
- Manage study documents and support eTMF management
- Support study teams to resolve data management queries
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Track and follow up with CRAs for outstanding issues
- Support in generating the study specific reports.
- Manage internal/external communications
- Assist in ensuring training compliance for study teams
- Manage study payments (Site and Vendor) – Ex: Payment reconciliation and release
- Review study performance dashboard


University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 05-08 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.


- Years of experience in the job discipline: 06-08 Years
- Years of experience in other professional roles: 00-05 Years
- CRAs with 4+ years experience into file review can apply. 


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