Phani Varma Email & Phone Number

India

• Single point of contact for the current organization pertaining to Data management.• Effectively handled as leader with whole responsibility on all the studies worked as Protocol Data Manager.• Handled and completed Study locks effectively for many studies.• Have regular clients calls and meetings to discuss the risk on any aspect of the studies.• Preapare Trial Health Risk summary slides and present then during clients calls with whole global study team.• Conduct Internal meetings regularly to understand and answer any questions from the team to ensure Data managment activities are smooth enough. else escalate accordingly.• Effectively handled as leader with whole responsibility on all the studies worked as Protocol Data Manager.• Single point of contact pertaining to Data management.• Created Database specifications and Edit check specficaitons.• Worked effectively in many migrations/post production changes and have performed validations and UAT for numerous studies.• Created study documents like eCRF completion guidlines, Data review plan, Quality control, Drafting timelines, Site closure or any for study requirement.• Collabrate with database developer as well as Accenture build and testing team to support the overall eCRF built, programmer.• Perform and review SDV plan for the study.• Provide inputs regarding study start-up activities and timelines to client as required.• Identify document risks and issues for start-up activities, develop mitigation plans and share with the client.• Analyze and review tumor data, Image reconciliations and BICR data.• Communicate with internal and external stake holders efficiently for the assigned protocols.• Worked effectively on post-production changes/migrations.• Review CRF build programming and UAT as needed and applicable.

India

• Worked as CDR on critical listings.• Worked effectively on RECIST 1.1, have complete knowledge on RECIST 1.1 tumor knowledge • Efficiently worked in Discrepancy management and QC activities for many studies.• Regular interaction with clients and highlighting study issues to maintain the health of the study.• Worked on many process improvements like metrics, recon process and crf corrections.• Worked effectively on study reconciliations. SAE, PK reconciliation• Mentored new hires.• Communication with Other stake holders like EDO, MM, Site managers to keep the study on track.• Allocation of work to other teams members and monitor QC review in order to catch up with timelines.

India

• Lead APAC team as lead CDA.• Handled few studies as a lead CDA.• Highly efficient in preparing metrics for studies and named as single point of contact for most of the studies.• Worked on many process improvements like metrics, recon process and crf corrections.• Worked efficiently on Patient data tracker.• Worked in oncology trails effectively.• Worked on PAD(Peripheral artery disease)• Worked in PDR activities. (Patient data report) as part of close up activities.• Worked effectively on study reconciliations. SAE, PK, IWRS, Covance etc study related recons.• Discrepancy management, QC activities. • Listing review (Manual, SAS listings, DRU tool) in Rave database.• Communicate sites for site related issues or clarifications.• Give study specific trainings to team members in various processes.• Mentored most of the new joiners. • Provide study status report presentation to client monthly.• Assigning tasks to the study Team.• LNR activity end to end process.Frequent communication with clinical team and coding team for resolution of issues.

India

India