Overview
Clinical Operations Specialist Jobs in Bangalore, Karnataka, India at Biocon Biologics
Job Description
1. To provide general administrative support to the Clinical Operations Department and assistance to clinical Project Manager(s) and Therapeutic area head (s).
2. To assist the clinical study team (CST) with selective aspects of trial management from start-up to close-out on the assigned projects.
3. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
4. Provides support in creating the Trial Master File(TMF/eTMF); with oversight, assists with maintenance tasks such as tracking and filing for the duration of the study, and with preparation for audits/ inspections and archiving.
5. Coordination for set-up, access requests, and maintenance for project systems (e.g. eTMF, EDC, Shared Drive).
6. To assist with maintaining and updating trial-related data in an existing database, (e.g. eTMF) which may require contacting internal team members to gather information.
7. Generates and formats study-related data in reports and compiles data as requested.
8. Supports the preparation and distribution of study-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets, and presentations).
9. Facilitates the receipt, collection, tracking, and review of trial-related documents.
10. Facilitates the planning, organization and execution of meetings (e.g. project-Kick Off meetings, internal team meetings, Client meetings etc).
11. To process data collection forms (i.e. log in, tracking,
quality control
) as appropriate for the study.
12. Responsible for maintaining clinical study team lists.
13. Supports with completion of relevant clinical study team training tracking.
14. Provide other study support to functional teams as directed by Line Management.
15. Ensures all required training is completed and documented.
16. Review trial documents for accuracy and completeness before placing them in TMF/ eTMF.
17. Review invoices received for the study and track/monitor the trial budget for each vendor for the assigned study.
Title: Clinical Operations Specialist
Company: Biocon Biologics
Location: Bangalore, Karnataka, India
Category: Healthcare, Administrative/Clerical
