Pooja Sharma
Global Trial Specialist | Project Management | Clinical Operations | Regulatory Affairs | Medical Writing | eTMF SME | CTMS | Global Trial Management | Budgeting | Lean Six Sigma Yellow Belt | MBA | Pharmacist
- Role
- Global Trial Specialist (Global Trial Associate) at 百时美施贵宝
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Pooja Sharma
A highly motivated and detail-oriented professional in clinical research with over 6+ years of experience in both the pharmaceutical and CRO sectors. Proficient in clinical operations, regulatory affairs, medical writing, business development, finance and executing Phase I-IV studies across diverse indications. Capable in project management across all stages, from Pre-award, Study Start-up, Maintenance to close-out. Possesses advanced knowledge of crucial clinical trial systems including e-TMF (Veeva Vault), CTMS, EDC, and IRT, etc. Experienced in supporting regulatory activities, including project implementation, change in scope requests, and creating proposal and budget documents for regulatory and medical writing projects. Skilled in fostering strong relationships with internal and external stakeholders and adept at managing project timelines for the timely execution of clinical trials.
Experience
Global Trial Specialist (Global Trial Associate)
Jan 2025 — Present · Hyderabad, IN
Supported Global Trial Lead (GTL) in driving study execution using performance metrics and quality indicators.Resolved routine issues and escalated critical matters with urgency.Actively contributed as a key member of cross-functional teams.Managed and collected study-level documentation, ensuring eTMF accuracy and completion.Reviewed vendor invoices, managed accruals, and processed LSD/SOW changes.Provided operational input for study startup, maintenance, and closeout activities.Facilitated vendor creation and payment processing with relevant stakeholders.Managed global vendor site lists, study mail-groups, and SharePoint/study directory updates.Organized study team meetings, set agendas, and captured meeting minutes.Identified and mitigated risks, escalating issues as appropriate.Participated in filing activities and supported audits as required.Led study closure and archival activities during the closure phase.
Education
Indira Gandhi National Open University
Master of Business Administration - MBA
Guru Ghasidas University
Bachelor of Pharmacy - B Pharma, Pharmacy
2015 — 2019
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