Lead Risk Based Quality Management discussion as datamanagement rep using RACT tool and help the team implement the RBQM on studies.Develop risk management strategies and proactively manage timelines toensure successful oversight and delivery of studies, projects and coding responsibilities, includingthe implementation and adoption of new technologies.Partner with relevant functions for external data vendor selection andmanagement. Oversee development of data transfer agreements with vendors ensuring use ofstandards, fit-for-purpose data models and transfer intervals.Act as experts for data collection, advising teams andstakeholders on best practices and proposing innovative solutions. Ensure a high quality of data andcompliance with applicable pharma industry regulations and standards.Stay current with and adopt emergent data collection, data management,visualization and provision tools andapplications to ensure fit-for-purpose and impactful approaches.Use data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in data to ensure high quality results.Data Curation: Organization and integration of data collected from various sources. Maintainvalue of data through application of FAIR (Findable, Accessible, Interoperable, Reusable) principles.Support Analyses: Partner with stakeholders to understand their data insight needs and offer DataDemonstrate a strong understanding of the data flow from collection throughto analysis and filing. Collaborate and contribute to functional/cross-functional initiatives or goalsto promote new ways of working, including emerging technologies. Enable broader and moreeffective use of data to support the business.Technical Consultant: Offer guidance and advice to peers within the function, to key stakeholdersand to FSPs, CRO and collaborative groups on technical solutions to ensure high quality datacollection and delivery. Deliver on solutions as needed.

Collaborate with peers within the CDM function and across the organization to identify, design and execute fit for purpose data management solutions, adhering to F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles. Ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs) and vendors, overseeing and providing technical expertise in the delivery of high quality data. Contribute to functional, cross functional, enterprise-wide or external initiatives. Having strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we collect and deliver data and to develop and deliver medicines for the patients.

• Manage a team of professional Data Management staff• Define resource requirements and work with supervisor to prioritize resource assignments across projects• Oversight of all the projects.• Directly responsible for utilization of staff• Assess and document competency of staff to satisfy position responsibilities• Regularly set goals and evaluates and documents performance• Participate in recruitment of new staff• Provide review and guidance for production of Data Management documentation or deliverables that are produced by the Data Management Function.• Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency for Data Management function.• Participate in the implementation of new processes and technology• Mentor staff members to develop Data Management process and system expertise• Primary customer interactions at project level with a focus on specific Data Management Function• Understand scope of work, budget, and scope assumptions. Identify out of scope work and contribute to estimating costs of this work• Ensure project milestones pertaining to Data Management Function are met according to agreed upon timelines with high quality

● Serve as primary data management point of contact for customers on assigned criticalprograms/molecules or tasks as applicable, being part of the Core Study management team atClient’s end.● People management. Have direct reportees and have performed appraisals for team members,being part of the interview panel.● Provide data management expertise and oversight while working with Study Management Teams(SMT), key decision makers, and internal team members to manage continuous processimprovements, issue escalation, workload projections, and provide technical expertise● Lead and perform study design for multiple Global Oncology studies.● Represent the Data Management team at F2F Investigator and CRA meetings● Strong communications with the Data Management team, Programming team, Project DataManagers (PDMs), Study Management Team (SMT) and all other stakeholders to manage andmeet study/program deliverables.● Serve as the second point of escalation for unresolved data issues; work with internal DM teamand vendors for resolution.● Train and mentor Associate Study Data Lead with data management expertise.● Support and prepare for internal/external audits and prepare the team members accordingly.● To ensure proper tracking of study efforts/budget into designated systems/tools as utilized for theproject.● To be able to generate and share study status at program level for management review andinsights as and when requested.

● Function as Data Team Lead on multiple global studies in Oncology through entire projectlife cycle of start up, maintenance and close out.● Work in the full service project providing inputs and guidance to technical designer, Raveprogrammer and SAS programmer.● Collaborate with core study team members; statistician, safety and clinical science andclinical operations.● Lead several project teams of 10-15 DM study team members as a Lead Data Manager(DTL), mentoring and establishing efficient process management. Responsible for trackingperformance and providing monthly feedback to the DM ops line management team on theproject team members.● Involved in customer maintenance, risk management, timelines and planning management,project finances and adherence to project budget.● Participate in internal and custom audits.

● Serve as a Data Operations Coordinator/Data Team Lead on multiple global studies.● Manage delivery of projects through a full data management process life cycle: Start up,conduct and close out.● With minimal guidance, manage project timelines and quality issues, determine resourceneeds, and identify and justify out-of-scope.● Perform comprehensive quality control procedures.● Independently bring project solutions to the CDM team.● Solves issues though using the global issue escalation/communication plan.● Meet objectives as assigned.● Develop and maintain good communications and working relationships with the CDM team.● Interact with CDM team members to negotiate timelines and responsibilities.● Responsible for the project ownership, mentoring and successful implementation of theproject.● Complete knowledge of the usage of data management tools RAVE and Inform andperforming all the activities of data management. Thorough knowledge of SDTMimplementation.● Complete knowledge of start-up activities in CDM. Development of data specifications,eCRF design, database requirements, eCRF completion guidelines, and edit rules/checks,writing test conditions and validation of sas listings and checks, UAT of front end edits,annotation and metadata activities, data transfer programming validation, collaborating withcross functional groups, handled migration.

● Identification and reporting of protocol deviations.● Ability to perform UAT, write test conditions for checks which go through validationafterwards, perform UAT of SDTM mapping, test data entry for SDTM mapping, validation ofSDTM CUT installation on data.● Perform SAE reconciliation using Safety database and Clinical database and regular followup with associates of Safety database. Reconcile other data streams, like electronic datatransfer.● Involved in post production migration also.● Work in close association with Clinical data programmers to understand the impact on thedatabase.● Validation of SAS data extracts and thorough QC of the same after which it is made availableto the project team.● Mentoring/training new hires or existing individuals on complete project related activities.● Trained on utilization of resources, cost, time and maintaining quality through MS projects.● Attending important meetings with sponsors on key issues like migration, amendments andedit checks or listings updates.● Assigning work on a day to day basis and bringing up newly recruited candidates to a certainacceptable level of working● Ability to address validations and perform various manual checks.● Have a clear understanding of Lab Data and coding issues.● To query for incorrect differential or missing units, missing metadata information higher andlower values compared to acceptable ranges and perform lab extreme checks.● Analyze lab related AEs and review as per toxicity grade.

● Proof read and QC transcribed report typed by Medical transcriptionist and interpret thedictation into diagnostic test results, operative reports, referral letters, and other documents● Review and edit drafts prepared by speech recognition software, making sure that thetranscription is correct, complete, and has a consistent style● Translate medical abbreviations and jargon into the appropriate long form● Identify inconsistencies, errors, and missing information within a report that couldcompromise patient care● Follow up with the healthcare provider to ensure the accuracy of the reports● Submit health records for physicians to approve● Follow patient confidentiality guidelines and legal documentation requirements● Enter medical reports into electronic health records systems● Perform quality improvement audits