Nilesh Damle

Associate Director @Syneos Health

Pune City, MH, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2023 — Present

Associate Director @Syneos Health

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IN

EDUCATION

2003 — 2005

University of Mumbai

Msc, Microbiology

SKILLS

MeddraMedical WritingCdiscLine ManagementCRO ManagementComputer System ValidationClinical Study DesignSix SigmaProject ManagementSdtmClinical DevelopmentMedidataLifesciencesDatabasesIch-GcpU.s. Title 21 Cfr Part 11 RegulationClinical TrialsOncologyProtocolData ValidationQuality AssurancePl/SqlOracleValidationManagementCdisc StandardsClinical ResearchCrf Design21 Cfr Part 11InformBiotechnologyElectronic Data Capture (Edc)PharmacovigilanceGmpCardiologyData ManagementGood Clinical Practice (Gcp)EdcTherapeutic AreasCRO

ABOUT NILESH DAMLE

I have an experience of 20 years in Pharma industry.Presently working in Clinical Research Data Management.I have been associated with Clinical Data Management for around 18 years.Have worked at Client location at Japan as a Lead Data Manager for 1.5 years, Project Management, study build activities, coordinating with Onsite client Data Managers and Offshore resources for delivering Clinical projects.Previously have handled All Data management activities like Query management, Central and Local Lab,PK,Gen,eDiaries ECG Reconciliation, Third party data Acquisition, IVRS/IWRS set up /reconciliations, Local Labs set up.Has worked extensively on building database for Clinical Trials.Has set up many EDC study database.hands on experience on EDC tools like Inform, RAVE,Clintrial etc.Basic knowledge of PL/SQL, Oracle 9i.Presently Involved in Coordinating the Offshore resources as per the Onsite Clients requirementsSpecialties: EDC tools like Inform, RAVE.Knowledge of Oracle.Clinical Database build activities.Third Paty system set up.Onsite coordination.Project Management.

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Nilesh Damle — Associate Director at Syneos Health in Pune City, MH, IN | Unifers