Pushpa Govind

• As required, may have line management responsibilities for a small team. Adhere to the relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.

• Acted as a back-up for Associate Director during ML taking care of the work allocation, resource management, metrics collection, reporting the risks in studies to Director level.

• Have been indirectly responsible for performance management & providing feedback to the AD with a team of 7.

• Lead/Responsible for the study set-up, technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical study(ies).
• Responsible for project delivery of multiple Clinical studies for all clinical data acquisition activities, including timeline management, oversight/governance of external vendors, driving team members to meet project timelines, etc.
• For studies, key responsibilities include:
o Act as an advisor for the Study Core Teams (SCT) members in providing DM operational/requirements about the eDC study set-up or vendor technical related activities
o Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
o Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations)
o Understands, mediates, and solves issues related to Data acquisition and escalates as appropriate to the Study Data Manager or Vendor
o Develops the study eDC application and associated documents including forms, data validation checks & data extraction and ensures delivery with quality and on time
o Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities
o Ensures quality control of deliverables
o Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.
• Acts as a Subject Matter Expert for core Data Acquisition activities like process improvements, new processes, training, quality assessments, audits and inspections.
• Acts as a mentor in their expertise area to shorten the learning curve of the more junior profiles and act as a reference model within the Data Acquisition team. AND Responsible for building capability, leading, and mentoring junior team members.
• When studies are outsourced either through an e2e DM FSP model or through FSO, supports the Study Data Manager & Oversight Data Manager in specific ePRO, eCOA, and other external vendor data matters or issues.

• Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems
• Provide technical expertise in conjunction with internal and external clients
• Program, test, and document databases in accordance with programming standards and validation procedures
• May serve as Lead Programmer on the corporate team
• May assist IT in developing and implementing new technologies
• May assist IT in testing and evaluating new upgrades to technologies
• May assist in developing, revising, and maintaining core operating procedures and working instructions
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables
• Develop and maintain good communications and working relationships with teams and external clients
• May interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables.

• Develop & design study & customize clinical trial using EDC
• Testing complete database to ensure quality
• Unit Test the eCRF and peer review as required
• Troubleshoot and ensure programming processes with best practices
• Handle Migration studies, Publish Checks, RSG (Rave Safety Gateway)
• Quality Review & Quality Control by preparing necessary test cases
• Interact with clients for all kind of communication efficiently & effectively.

• Serve as a Subject Matter Expert and point of contact for technical issues from Tier 1 support, once in production
• Annotate CRFs and configure EDC databases and eCRFs, edit checks, and visit schedules
• Perform the necessary quality control steps to confirm the study is built in accordance with approved specifications
• Participate in peer review of databases developed by other Study Builders
• Understand and apply client standards to each study build
• Support any updates or changes to the study (e.g
• Protocol amendments); conduct change control process, and proper version control process, to production studies for both requested and approved changes
• Resolve and update issues arising from UAT including study database, eCRF and edit checks
• Assess requirements and / or specifications, provide work effort estimates and provide the Study Designer with an estimated turnaround time, based on the approved design specifications
• Identify design issues, provide recommendations, and raise to the Study Designer in a timely fashion
• Be familiar with, and/or have experience and understanding of all tasks and responsibilities associated with DBC and Edit Developer
• Provide programming or other support and assist CDM managers in daily technical operations
• Respond to and solve technical oriented problems in a timely manner, as appropriate for the position
• Provide feedback, suggestions for improvements to the design specifications or process
• Track against the established timelines and provide regular status updates to the Onshore Liaison.

• Manage and coordinate the delivery of technical aspects for SDTM mapping of EDC trials using the Inform EDC software, Table Trans mapping software, and related standards and processes
• Coordinate the specific activities for all studies with each study designer
• Prepare and finalize plans for delivery of SDTM Mapping Specification, Define.xls and other technical deliverables for each study timeline
• Lead the technical specification and development efforts for assigned deliverables for EDC
• Responsible for building study databases, updating databases as and when required and review / reconciles views against the study build
• Once the database has been peer reviewed and approved, perform the activities required to put the study active
• Peer review databases built by others
• May copy/customize procedures
• Work with study designers and team leads to promote consistent operations, efficient use of resources and sharing knowledge/best practices
• Support management of CDM in achieving common goals
• Promote teamwork within assigned therapeutic areas
• Find common ground, communicate and proactively share information
• Propose new and revise current procedures as appropriate.