Sharfaa Tabassum
Senior Manager,clinical data management at Viatris,Alumni IIM Kozhikode
- Role
- Senior Manager at Viatris
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Sharfaa Tabassum
Have a total of 17years of experience in clinical data management. Experience includes working in CRO and pharmaceutical company.Individual contributor working as a lead data manager, performing oversight for all the studies outsourced. Experienced working globally in a cross cultural environment with remote peers and vendors. Managing studies end to end from protocol review, eDC set up, manage conduct, data base lock and CSR activities for phase 2 to phase 4. Managed complex studies and proven to deliver quality data. I am self driven, motivated, clear thinker, issue resolving, team player.
Experience
Senior Manager
Mar 2022 — Present · IN
Oversight Clinical data manager with 16+ yrs experience in Clinical data Management. Lead the team through build requirements, timelines & start up activities, including review & approval of all eCRF, completion guidelines, Validation-testing documents, Data Transfer Agreements. During maintenance, review eCRF data, CRF metrics, Vendor review reconciliations. Demonstrated managing 4+ studies independently- end to end activities from start upto DBL with minimal to no support. Have good understanding of the portfolio & indication to identify & assist DM process application. Also, support in CRO selection, bid defense & CSR activities. Proven to be strong team player with good communication skills. Provide effective feedback to CRO for DM improvement & initiatives. Have participated - faced HA inspections, audits for Data management activities.
Education
City College, Bangalore
Msc, Biotechnology
2004 — 2006
Skills
- Clinical Research
- Oracle Clinical
- Inform
- Cdisc
- Pharmaceutical Industry
- Sop
- Edc
- Gcp
- 21 Cfr Part 11
- CRO
- Validation
- Rave
- Data Management
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