Feb 2022 – Jun 2023 · 1 yr 4 mos

Apr 2019 – Jan 2022 · 2 yrs 9 mos · India

• Client Management
• Significant role main point of contact for customer on data management deliverables
• Pivotal role of providing project management expertise working with customer data managers, key decision makers, internal team members to manage continuous process improvements/ issue escalation/ workload projections
• Accountable for providing input for and performing direct negotiations with customer such as - timelines, financial, process, resources
• Safeguarding open communications with customer and Quintiles management to manage & meet contractual obligations
• Service Management
• Engaged in meeting Data Operations Coordinator (DOC) and/or Data Operations team members on daily basis to ensure milestones meet timelines and quality deliverables
• Key role in establishing robust communications with data operations team, functional leads, project managers and all other stake holders
• Efficiently supported DM service delivery with comprehensive DM process and technical expertise in executing projects
• Served as the escalation point for unresolved data issues; with guidance, worked with client data managers, vendors, internal team members for resolution
• Integral role working with functional manager(s) to safeguard appropriate resources are assigned to meet project deliverables
• Strategic role involvement in gamut tasks such as – create and/or review and sign-off on all data management plan (DMP) documents; implemented proactive quality management plan; identified service / quality issues with agreed upon specifications per the DMP and contract / SOW; tracked service performance; provided leadership to identify root causes of issues and implemented remedial actions
• Diligently identified compliance issues; worked with functional managers ensuring timely follow-up/resolution; maintained internal tracking databases and systems

Jan 2015 – Mar 2019 · 4 yrs 2 mos · Bengaluru Area, India

• Key deliverables:
• Proactively coordinates and performs start-up, processing and finalisation activities as detailed in our SOPs.
• Project budget awareness and proactive management of timelines and projections.
• Successfully delivered Data Management deliverables in accordance with internal and external company requirements.
• Proactively managed project quality through supervision and Quality Control of team member’s work.
• Participation in reviewing and responding to QA audit reports.
• Proactive participation in appropriate sponsor/project team meetings.
• In Lead CDM role acted as key data management contact for the project.
• Lead and/or participate in User Acceptance Testing for projects as needed.
• Active involvement in departmental and organisational meetings and initiatives.
• Assisted with development and documentation of departmental procedures.
• Participated in the review of cross functional department procedures.
• Training and Mentoring of team members in accordance with established departmental procedures.
• Proactively coordinated and performed start-up, processing and finalization activities as detailed in our SOPs.
• Lead study setup including design, database structure, document creation including approvals.
• Communicated with cross functional groups throughout the project lifecycle.
• Monitored project scope.

Apr 2010 – Nov 2014 · 4 yrs 7 mos · Thiruvananthapuram Area, India

• Key deliverables:
• Acted as point of contact for clinical studies
• Performed data management activities to ensure the generation of accurate, complete and consistent clinical databases.
• Identified and escalated data issues to Study lead and provide training to new resources.
• Performed Serious Adverse Event reconciliation in accordance with all applicable procedures
• Allocation of work among project team members. Ensuring timely delivery of each task within the overall study timelines.
• Performed additional data review activities to provide high quality data.
• Represented department during client visits and audits.
• Liaise with different departments for project requirements.
• Performed UAT, create specification for programming listing, listing testing.
• Communicated with all stakeholder throughout the course of study.

Oct 2009 – Mar 2010 · 5 mos

• Key deliverables:
• Performed the daily review of CRF’s for completeness, accuracy and consistency.
• Identification of data discrepancies via computerized edit checks and manual data checks.
• Reviewed, updated and corrected data in the clinical database based on resolved data queries.
• Updated tracking systems as necessary.
• Accurately performed external data reconciliation in accordance with all applicable procedures.