Sameer Darekar Email & Phone Number

Thiruvananthapuram, Kerala, India

Navi Mumbai

Perform data management activities on the assigned project in a timely and efficient mannerGenerate queries to clarify and improve the quality of the dataTest and execute validation proceduresProvide inputs to the CRF layout as per protocol requirementIdentify the need of new standards and coordinate with CSU Data ScientistResponsible for database review, testing and UAT of edit checks specifications for assigned studiesCoordinate with CRAs for timely resolution of queries

Pune Area, India

Identification, categorization of various documents generated in Clinical Trials. Verify all the Documents related to CDM (DMP,DQP,DVP)Renaming, clinical documents (DCF, CRF, FDF), safety documents (CIOMS,MEDWATCH) received from the ClientUploading documents in clients database using in-house build software RAPID-DOC into documentumMap the attributes into the respective spreadsheet after scrutinizing the each documentEnsuring that documents generated in electronic format are named properly and meta data is captured in accordance with client’s SOPVerifying if the document is complete, legible, named properly & data is captured as per client’s SOPAdherence to all rules and regulations governing the process- ICH -GCP Guidelines and 21 CFR Part 11 (Electronic Records and Electronic signatures)

Professional Diploma In Clinical Research

M.Pharm, Pharmacology

Masters of Pharmacy in Pharmacology

B.Pharm