Kajal Lokhande

A Healthcare Professional with 5 + years of experience in Phase I to IV Open Label as well as Blinded trials. Having work experience in Clinical data management from study startup to database lock. Good understanding of ICH/GCP guidelines, 21 CFR etc, Proficiency in EDC- Medidata RAVE, Veeva Vault, iMednet, Zelta(IBM), Clindox. Aims to leverage expertise in data management and interpretation to assist in making informed decisions that improves the highest level accuracy in data reporting.

Sr.Clinical Data Analyst - Fortrea(Formerly Labcorp)

(2022-10)

Working as Data Analyst includes various responsibilities such as performing and mentoring to the team for study related activities i.e Discrepancy management, Page Review, Vendor reconciliation, SAS listing, Programmed listing review, CPT report.

• UAT, Creation of Non EDC review tools specification (SAS edit check and listing specification), validation activity.
• Change control and Study related metrics preparation.
• CRF Freezing and archiving etc.
• Working on different therapeutic areas - Oncology, Virology, Observational etc.

Clinical Data Management Associate - Jehangir Clinical Development Center (JCDC)

(2021-07 - 2022-10)

• Developing CRF Specification using approved paper CRF
• Creation of CRF completion guidelines
• UAT Script writing/Testing
• Discrepancy management and DB Lock activities
• Performed holistic data review using all the study specific reports with profound understanding of protocol and eCCG.
• Provide support to sites.

MBA - Hospital and healthcare management - Pune University

Bachelor's - Biotechnology - Pune University

Post graduate program - Clinical Research

Post graduate diploma - Clinical Data Management