Travelling
Bhagyashree Sawant
Clinical Study Associate
Thane,Maharashtra
Summary
To be part of a professionally managed team that would provide an opportunity to contribute my experience and expertise towards achieving organization's mission, eventually gaining professional growth.
Overview
7
7
years of professional experience
3
3
Languages
Work History
Clinical Study Associate
Tata Consultancy Services
09.2020 - Current
- Responsible for providing operational support to multiple global
study management teams (SMTs) through all phases of clinical
study management (Plan, Start-up, Conduct and Close-out) in
accordance with appropriate quality standards including ICH/GCP
and applicable regulations. - Updating and maintaining systems within project timelines/plans.
- Extract Reports and send it to appropriate stakeholders.
- Maintain Study level data in the CTMS.
- Look after the access to systems for study and site staffs.
- Ensure all the site and country level data is complete in the trial
systems. - Upload and check the documents in the eTMF.
- Perform periodic reviews of the TMF to keep it inspection ready.
Support GSMs and GSL during inspection. - Maintain safety contacts and review safety reports and provide to
the safety contacts. - Creation and timely maintenance of the trackers and dashboards.
- Provide support in creating newsletters.
- Attend scheduled meetings with the country operations team and
vendors. - Resolve issues and queries raised by the CSMs and CRAs.
- Provide training materials to the site staff related to the study.
- Arrange virtual meetings with GSMs on weekly basis to discuss
process improvement strategies, study milestones achieved, future
goals and decisions to be taken. - Monitor if the systems used are maintained and are compliant to
the study protocol and meeting the regulatory guidelines and
standards. - Trained and worked on systems used during the trials.
ETMF Document Specialist
Tata Consultancy Services Ltd.
12.2019 - 09.2020
- Act as a document creator / QC'er / primary contact for all issues
related to TMF processing and inspection readiness. - Collaborate with the eTMF Team Lead in order to ensure
alignment of processes across all Roche Functions - Deliver quality control measures and communication of relevant
Roche TMF issues and challenges to the Sr. eTMF Document
Specialist as the first line. Followed by the eTMF - Provide input into functional SOPs, guidelines, and system user
guides as related to the accuracy and completeness of TMF. - Perform discrepancy management in accordance with the
process guidelines and timelines. - Provide support during internal and external inspections by
regulatory bodies.
Jr. Officer
Inventia Healthcare Pvt. Ltd
08.2017 - 01.2019
- Preparation & Revision of Batch Manufacturing Records & Batch Packing Records for Domestic, Semi-Regulated and Regulated market through DMS System
- Maintaining the Records of Obsolete & New Documents
- Follow up with the reviewer and approver for timely review and approval of the BMR & BPR
- Verification of the documents before Issuance for Production.
Education
Post Graduation Diploma - Clinical Research
Clinomic Centre For Clinical Research
Thane 04.2001 -
B. SC (Bio Tech) -
Mumbai
H.S.C - undefined
Mumbai
S.S.C - undefined
Mumbai
Skills
Flexibility and Adaptability to work in any environment
Willingness to accept any challenge irrespective of its complexity
Good observation skills & fast learner
Technical, logical and innovative view towards the given project
Good communication and permissive attitude
Personal Information
- Date of Birth: 10/02/95
- Marital Status: Single
Interests
Watching Movies & TV Series
Dancing
Cycling
Exploring New Cuisines
Timeline
Clinical Study Associate
Tata Consultancy Services
09.2020 - Current
ETMF Document Specialist
Tata Consultancy Services Ltd.
12.2019 - 09.2020
Jr. Officer
Inventia Healthcare Pvt. Ltd
08.2017 - 01.2019
Post Graduation Diploma - Clinical Research
Clinomic Centre For Clinical Research
04.2001 -
B. SC (Bio Tech) -
Mumbai
H.S.C - undefined
Mumbai
S.S.C - undefined
Mumbai