Sushma Reddy Email and Phone Number

Responsible for Data Management activities managed by CRO from study startup to closeout.Involved in Schizophrenia and Alzheimer's studies.Review protocols to ensure data collection, database and reporting requirements can be met and standardized across the program.Review DMP/DVP and other relevant study documents, provide input and feedback to CRO and ensure quality and standardization.Responsible for providing updates to the study team regarding action/issues logs, status sheets, and timelines during study team meetings.Working with different vendors at study start up level, reviewing and approving DTAs.Involved in SUAT and Data review activities as per DVP.Ensuring data captured accurately and queries are closed timely.Conducting data quality reviews with clinical teams to ensure accuracy, consistency and reliability of data.Reviewing monthly metrics, vendor issues, reconciliation status, to bi-weekly review during interim data cleaning/submission.Ensuring all the DM documents are updated regularly and filed accordingly in TMF.Reviewing Study close-out activities checklist and proceeding as per the list and following up regularly with CRO as per the checklist.Working with the Stats team throughout the study for ensuring data quality.

Serve as point of contact for all sponsor communications and communicate the study updates within the team.Involved and reviewed various phases (Phase I, II, III) of multiple Oncology studies.Develop the database design requirements, including configuration and developing and maintaining client design standards as applicable by the requirements of the Clinical Protocol.Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management.Responsible for providing updates to the Project Manager regarding action/issues logs, status sheets, and timelines during the start-up phase.Lead in the development of sponsor-specific standards and program-specific set-up procedures.Review the progress of the study status and update the necessary information with the respective department Leads.Ensuring the training of the team involved, is done as per the SOPs.Plan, coordinate, and supervise the DM activities.User acceptance testing, discrepancy management, and manual data review.Data reviewing using Manual listing, Rave reports, and J-Review reports.Responsible for third-party data reconciliation, SAE Reconciliation, and ensuring all queries related to reconciliations and medical coding are closed as per the timelines of the study conduct.Ensuring all the DM documents are updated regularly, and the team’s DM metrics are followed up.Preparing Study close-out activities checklist and proceeding as per the list.

Collaborating with the clinical project manager along with the team, to determine study timelines and milestones.Participates in the review of clinical documents. (Protocols, Case report forms).Developed Data Management Plan (DMP).Preparation of SOPs as per the DMP and conducting training for the team.Involved in database design, development, and testing through collaboration with clinical programmers.Involved in planning, managing, reviewing, and implementing in-house and outsourced oncology-specific data management activities.Ensured quality standards are met for patient data in clinical databases through data cleaning processes and audits.Preparation of eCRF Design Specifications, as per the Protocol, and annotate eCRF as per the SDTM specifications.Verification and approval of final eCRF.Preparation of eCRF completion guidelines.Preparation of Data Validation Specification spreadsheet (DVS).Creation of test scripts and Performing UAT for the programmed validations (Edit checks and custom functions).Performing Query Management activity, monitoring queries by following Query tracker report and reviewing reports for manual data review. Communicating with the site, ensuring timely closure of all raised queries.SAE Reconciliation and lab data reconciliation.Following DM metrics regularly and proceeding to the closeout accordingly as per the timelines.Performing final data review and performing soft lock and hard lock of the database.

Study Build Experience • Designing of CRF• Responsible for CRF Annotation following SDTM standards.• Preparation of eCRF Architect loader specification(ALS)• Preparation of Visit-Folder-Matrix(VFM)• Preparation of study data validation specifications( DVS)• Involved in User acceptance testing activities(UAT)• Creating folders, forms, fields, data and unit dictionaries, Matrices.• Responsible for programming Edit Checks.• Performing migration and Publish checks activitiesStudy Conduct Experience • Prepare Case Report Forms (CRFs) and CRF completion guidelines• Responsible for creation and implementation of Data Validation Plan• Prepare data management plan draft copies and make corrections as suggested by data managers• Perform data entry screen testing which includes dummy data entry and report all errors in the error log form• Interact closely with the database programmer/designer for database testing• Perform data entry for edit check testing (Clean and Dirty Patient data)• Responsible for Discrepancy Management• Creates, review and process Data Clarification Forms (DCF) and update database• Conduct reconciliation of SAEs and raise data clarifications forms as needed• Performs reconciliation of laboratory or any external (third party) vendor data • Establish and coordinate timely completion of the database lock procedures• Update all relevant tracking spreadsheets on an ongoing basis

Company Description: “MaxisIT® is the only Integrated Software Platform for biopharmaceutical industry’ Clinical Development. We offer self-service data preparation and analytics products including clinical data repository, Metadata Repository, data management, data integration, statistical computing, advance analytics, reporting and visualization that are regulatory compliant, validated, cloud-based and delivered through alternate models viz. Enterprise SaaS, On-premise deployment, or as a Hybrid software-enabled service. Since 2003, we have grown completely organically with a strong belief in our idea of “Empowering Biopharmaceutical industry with Integrated Computing, Self-Service Analytics, and Enterprise Externalization”.