Centralized Study Specialist II (Clinical Operations)

Job Location(s) IN-Bangalore
Job Number
Job Category
Clinical Operations Entry Level
Position Type

Job Overview

- 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.
- 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.
- Track and report metrics as determined by management according to required timelines.
- Assist with the implementation of revised processes and procedures.
- 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.
- Assist in Investigator Payment Processing
- Assist the study start up teams with tasks required for site start up activities.
- Manage and support assigned studies for upload as per set objectives
- Follow up with study team on uploading queries
- 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 & access management
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in e-TMF management activities
- Support study team in data review and support activities.
- Support in generating the study specific reports.
- Data Review: Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks. and Assist the Lead for any study specific data review related tasks.


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 02-03 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.


- Years of experience in the job discipline: 02-03 Years
- Years of experience in other professional roles: 00-03 Years
- Other required work-related experiences:
- Demonstrated ability to organize and communicate effectively.
- Demonstrated ability to pay attention to detail.
- Ability to work well with others.
- Ability to deliver consistent high quality of work.
Ability to use computer and departmental tools


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