Pinky Kumari
Senior Clinical Process Associate /Site File Associate I /e-TMF Specialist at IQVIA Biotech (IQVIA)
- Role
- Business Process Svcs Senior Analyst at Accenture
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Pinky Kumari
Clinical research professional with 10+ years of hands-on experience in Trial Master File…
Experience
Business Process Svcs Senior Analyst
Aug 2022 — Present · IN
TMF Specialist /SMEResponsible for reviewing and supporting activities as assigned to maintain highquality, timely and inspection ready TMF For each assigned study, performed TMF Review activities, compliance with SOPsand WPs Perform TMF Quality Review for in-licensed TMFs at all levels (HQ/Country/Site) Resolve gaps identified during TMF quality review by collaborating with stakeholdersand action owners Trial File Maintenance in electronic document management system(CREDI/Subway/NCV or the CRO eTMF system) Perform TMF Quality Review for outsourced TMFs at all Levels (HQ/Country/Site) Additional tasks supporting missing Expected Document Placeholder and SignpostsReview and creation, conduct Post-Approval quality review of eTMF documentationand reconciliation Conduct planned review activities Being a SME leads/drives discussion and related activities Mentoring new hires and assist in training and ongoing process change Assist in new hiring and interview process as required Proactively identify risk and suggest changes to overcome changes SOP Preparation, Ongoing document upgrade Prepare Deviation and CAPA for respective errors and ensure preventive measureare in place Leads the development, creation, and maintenance of the eTMF Plan and TMF Indexwith Project Manager/Study Lead/or Sponsors Arrange ad-hoc meetings with study team members to work on and discuss ongoingactivities when applicable Assisting in internal or external audits and inspections for assigned studies Facilitate completion and closure of the eTMF at the end of the Study
Education
Punjab Technical University
Master's degree
2007 — 2009
Magadh University
Bachelor's degree
2001 — 2005
PES University
Post Graduate Diploma
2015 — 2016
Skills
- Openclinica
- Edc
- Medical Writing
- Leadership
- Customer Service
- Management
- Clinical Trials
- Sas
- Biotechnology
- Crf Design
- Crf Designing and Annotations
- Pharmaceutical Industry
- Microsoft Office
- Sales
- Pharmacovigilance
- Regulatory Affairs
- Marketing
- Clinical Research
- Project Management
- Microsoft Excel
- Ich-Gcp
- Business Strategy
- Life Sciences
- Clinical Data Management
- Training
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