Overall accountable for delivery of all relevant data operations activities from strategy planning database
setup to database lock.
Demonstrated excellence in outsourced as well as in-house data management activities.
Provide continues DM solution & leadership to team.
Team management: hiring, goal setting, mentoring, resource utilization, performance evaluation.
Well versed with entire data management process (project set-up, conduct and close out).
Strong grip on creation/review/ approval of DM documents.
Experienced in eDiary, medical device trials. Assisted pre-sales & business development team.
Budget management (POs, Invoices)
Excellence in CRO/vendor management and service delivery management
Proven experience in clinical system validation.
CRF part 11 requirement. Experienced in review of clinical system validation documentation.
Facilitated & audited by many internal and external audits and faced inspection. Creation/review of standard operating procedure (SOP).
Knowledge of CDISC standards (CDASH & SDTM), review of Pinnacle 21 report, SDTM package etc. Represent the organization on various data management forum.
Presented on SCDM conference 2016 on Impact of technology in future Clinical Trials.
Published paper on Leveraging digital technology in clinical trials (SCDM data basics 2018).
SCDM EMEA steering committee member & SCDM COVID-19 webinar task-force member
