Abhishek Shankhdhar

Clinical Trial Manager Ii at Syneos Health, Working for Bms Rco India Fsp @Syneos Health

Mumbai, MH, IN
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+91 *********19

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WORK HISTORY

Oct 2024 — Present

Clinical Trial Manager Ii at Syneos Health, Working for Bms Rco India Fsp @Syneos Health

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Mumbai, IN

Roles and responsibilities: 1- In the RCO team as CTM Perform the country specific study feasibilities, site feasibilities, update the CTAWB. In coordination with local GRS team prepare the CTA application for priority and non priority studies.3. Update the study planning in CTMS from initial planning and maintenance point of view.4. With the support from RDL, GTM and country manager, execute the site feasibilities, site selections, CTAg executions, Budget Development.5. Work with CRAs for routine day to day activities as CTM for all the studies.(Clinical operations management)6. Participate in DQST and CPGs ensuring the quality of the data, patient safety other study objectives remain within the acceptable quality limits.7. Mentor the junior team member and assist the new joiners in onboarding.

EDUCATION

2001 — 2004

Mahatma Jyotiba Phule Rohilkhand University

B.Sc, Botany & Chemistry

2004 — 2006

Mahatma Jyotiba Phule Rohilkhand University

M.Sc., Botany/Plant Biology

SKILLS

PharmacovigilanceIch-GcpClinical DevelopmentMedidataGdnGlobal Delivery NetworkClinical ResearchLate Phase StudiesEdcCtmsGcpPharmaceuticsClinical OperationsRave MedidataAlmacData AnalysisChemistryProject ManagementGood Clinical Practice (Gcp)Clinical Data ManagementCROTrainingClinical TrialsCRO ManagementElectronic Data Capture (Edc)Clinical MonitoringClinical Trial Management System (Ctms)Life SciencesRegulatory AffairsLifesciencesTeachingPharmaceutical Industry

ABOUT ABHISHEK SHANKHDHAR

With 18+ years in clinical trials and operations management, I bring expertise across study implementation, design, protocols, source verification, quality assurance, audits, and project management. I have successfully led cross-functional teams, supported regulatory dossier compilation, and contributed to CSR finalization. Recognized with Bravo, Shout Out, spot light, and ACE awards, I have consistently delivered on complex studies while mentoring CRA development programs. My strengths include clinical project management, trial monitoring, safety reporting, and risk-based monitoring, with a proven ability to drive study success and operational excellence.

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Abhishek Shankhdhar — Clinical Trial Manager Ii at Syneos Health, Working for Bms Rco India Fsp at Syneos Health in Mumbai, MH, IN | Unifers