Rukma Pawar
Bengaluru,KA
Summary
Organized and motivated clinical research professional with 3.8 years of experience, with a proven record of efficient management of clinical eTMF Document specialist. Adaptable, Transformational and organized team player with the ability to work independently, and develop opportunities that further establish organizational goals.
Overview
4
4
years of professional experience
1
1
Certification
Work History
ETMF Quality Reviewer
Accenture Solutions Pvt.Ltd
Bengaluru, KA
08.2020 - Current
- Perform quality review of documents submitted for entry into TMF and Discuss critical issues with eTMF Lead, if required.
- Strong knowledge of applicable regulations and guidelines with respect to regulatory documents.
- Providing back up management support to Seniors and other team members.
- Perform self evident corrections for issues specified by
clients. - Upload documents to eTMF as needed.
- Mentoring of new hires in eTMF.
- Process study documentation in accordance with standard operating procedures, work instructions GCP, ICH Guidelines and study specific.
- Worked in eTMF DM project to make sure Data
management related documents are residing in veeva
vault for inspection readiness. - Worked with PDM and DML for multiple studies related to
data management work to align with required
guidelines. - QC of the Data management work and Reconciliation
will be done for the studies (Rave, NEW CO, OC) and will
follow up with PDM and DML to make sure all DM related
documents are corrected and ready for inspection
readiness. Helping Lead in data management work in monthly
completed studies. - Attended meetings and trainings to advance professional knowledge and soft skills.
- Supported continuous improvement initiatives by actively participating in team meetings, trainings, and workshops focused on enhancing reviewer skills and processes
Education
Master of Science - Biotechnology
Akkamahadevi Karnataka State Women's University
Bijapur, India07.2019
Bachelor of Science - Science Education
S.B Arts And K.C.P Science College
Bijapur, India07.2015
Skills
- Trial Master File
- Software - Veeva Vault
- Written and Verbal Communication skill
- Organizational and Time Management skills
- Clinical Trials/ Clinical Operations
- GCP/ICH Guideline Competency
- Analytical skills
- Organizational skills
- Teamwork and Collaboration
- Microsoft Office ( Word, Excel, and Power Point )
Certification
Post Graduation Diploma in Clinical research by XLcareer Bengaluru Karnataka.
Data Management for Clinical Research by Coursera.
Learning Microsoft Power BI provided by Microsoft.
Learning Data analytics Basic from Microsoft self training.
Started learning SQL.
Timeline
ETMF Quality Reviewer
Accenture Solutions Pvt.Ltd
08.2020 - Current
Master of Science - Biotechnology
Akkamahadevi Karnataka State Women's University
Bachelor of Science - Science Education
S.B Arts And K.C.P Science College
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