 Worked as the Lead Clinical data manager and functioned as primary point of contact for clinical data management issues for the study team. Responsible for the Clinical Data Management (CDM) operations which includes Protocol Conversion, eCRF design, Edit Checks design and related EDC components, Data Verification, Data Review, Query Management. Managed the sites and coordinated any error resolution using data clarification forms (DCFs). Identified process gaps in CDM area and made recommendations for improvement. Creates and maintains SOPs related to CDM activities. Lead the development of quality objectives for each project; Adoption and implementation of established standards and processes; and identifies areas where new standards are needed. Interfaced regularly with staff in other departments and with external vendors (CROs) to resolve issues and to build efficiencies. Managed developing guidelines/checklist that aids in streamlining of activities for data management during closeout. Liaised with monitor, medical coding, data base programming and statistical programming teams to ensure smooth functioning of studies. Created annotated CRFs based on the study protocol and CDASH requirements. Performed freezing and locking of the data for statistical review, blinded interim quality review and final database lock. Sets expectations for the CRO and defines specifications for data transmission.  Ensures that SDTM compliant data is available for analyses together with the responsible Project Data Manager (PDM) Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance Effectively managed assigned projects by adhering to established timelines and deliverables. Developed and reviewed data management plans and data validation plans. Designed case report forms (CRF) and created edit check specifications.

 Developed study documents like Data Validation Plan, CRF Filing Guidelines and Data Entry Guidelines. Conducted study set-up, validation, and implementation of clinical databases.  Developed CDM timelines for assigned studies with input from study team and all relevant functions. Performed the database testing and database audit as part of Quality Control. Provided training to newly employed clinical data managers and guided other colleagues of the project. Developed test cases and performed UAT of edit checks and validation of manual listings. Performed studies as per the basic protocol requirements, SOP’s, ICH GCP and Standard Guidelines. Worked on Lab reconciliations including Local labs and central labs. Created Data transfer agreements, worked with the vendors on regular imports and reconciling the data. Ensured all the CDM activities are compliance with FDA regulatory standards (21 CRF part 11) Ensured effective and accurate collection, database entry, review, and reporting of safety data. Designed CRF as per study requirements by coordinating with clinical team. Responsible for supporting database locking activities, including planning, and executing listing reviews and identifying remaining clinical and monitoring tasks. Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Coordinated, facilitated, and participated in all data management activities from initiation of protocol through database lock for Phase (I-IV). Involved in study specific meetings, attended project team meetings, worked closely with the cross functional team, and meet the timelines. Mapping of data trends with the site and delivering them to Clinical team.

 Involved in writing and reviewing CRF completion guidelines. Worked with database developers in designing the database, data model, testing and implementation of the study databases. Demonstrating data review process with the sponsors and auditors when required. Point of contact for studies for the client, giving study related presentations to the clients. Maintained DMP throughout lifecycle of study project and ensured DMP is followed according to study design and requirements. Performed database testing and database audit as per Quality Control. Involved in the review of clinical research documents (e.g., Protocols, Case Report Forms, Reports and Statistical Analysis). Developed database clinical trial data specifications, including eCRF design, user requirements, edit checks, query logic and data validations. Identified errors, inconsistencies to generate reliable data providing feedback to the clinical team on protocol and CRF design. Reconcile electronic data transfers from vendor to sponsor. Developed test scripts and execution logs for User Acceptance Testing (UAT). Reviewed clinical research study protocols. Executed SAE reconciliation and external vendor data reconciliation for several clinical trials. Worked and used dictionaries including MedDRA and WHO Drug. Freeze and lock data as appropriate in time for statistical review and for quality review.

 Involved in writing and reviewing CRF completion guidelines Review data management plans and data validation plans  Performed clinical trial data management activities for Phases I to IV Participated in database designs and forms development Reviewed and tested eCRF screen design and written data management plans for EDC and paper-based trials Involved in creating Edit check specification and performing UAT using Phase forward INFORM Performed QC of data for several trials Interacted with the sites and CRA to coordinate error resolution using data clarification forms Worked with external CRO Generated and resolved queries via Oracle Clinical and INFORM Executed SAE reconciliation and external vendor data reconciliation for several clinical trials Responsible for supporting database locking activities, including planning and executing listing reviews and identifying remaining clinical and monitoring tasks Responsible for aiding in the closing of a database for a deliverable to the FDA  Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on electronic data capture tools