Managed a team of 16 from fresher to senior level, guided and backed each with adequate and sometime minimal resources and managed to achieve back-to-back timelines with quality delivery.There were 1200+ open queries and multiple open issues on vendor part for a transitioned study which had IA in 4 weeks, with continuous support and timely tracking the team was able to deliver 95% clean data considering short timespan for cleaning activity.The same project received 4.5 CSS score from sponsor under leadership and efficient data delivery.Through my regular connect with leads I was able to avoid an escalation.Resolved conflict between two of my team members.Timely identified the performing and non-performing member and took honor in appreciation them under different category according to there performance, and helped and guided the nonperforming once to improve their performance and efficiency by putting them under PIP and successfully coming out of it.Actively participated in cross functional managers meetings by leading the meetings and sharing the MOM and action items.Produce Monthly/Quarterly metrics/Dashboard as assigned or when requested by seniors.Participated in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.

Worked as a PCDA on setup study, created study documents and performed the UAT for checks, screen, and DB. Successfully delivered DBL for 2 study, where we worked as a 3rd party to another organization, my work was appreciated by the sponsor and on there request my contract was renewed and later I was directly hired by the sponsor to work with them.

Was working as team lead for a complex setup Oncology study, wrote 600+ edit check with no reference document that to on word document as per organization process, performed UAT for these check in short span of a month only with minimum error and re-writing. Represent the CDM team in IM (investigator meeting) and trained the CRA and site personal on the structure and data entry details of CRF.

Worked as Data Operations Coordinator (DOC) for multiple global studies, achieved 4 DBL and acted DML backup in their absence. Determining resource needs (with guidance from DTL or Manager) and Identify Out of Scope Work (SAS listing and Manual review listing for few checks).Have trained new joiners on process related platform and trained team member on various study specific SOPs and activities.Created all the setup related documents and kept track of the study documentation on timely manner without any document issue.

Have worked on developing Edit Check Specifications, test scripts, CRF designing, Data Handling Plan, CRF completion guidelines and worked on User acceptance testing of Screen and Edit Check Specifications. Perform ongoing manual data review, validation, and data lock activities for assigned trials.To maintain and update the entire study files as per the requirement of the protocol.

Responsible and accountable for Query generation and resolution and keeping track of all the discrepancies related to the resolution.Monitoring on the assessment schedule and keeping a tab on whether the patient is taking his dose on time and following the given protocol schedule.