Rupashree Raju

• Leadership and project coordination of all data management activities in project/study from protocol development to submission.
• Responsibility for quality and location of Sobi’s clinical data.
• Ownership for DM project deliverables and and management of DM-specific timelines.
• Support clinical study teams through the evaluation of CROs during the outsourcing process, ensuring that the selected CROs DM processes are in agreement with regulatory requirements and Sobi standards.
• Input to relevant strategic study documents i.e. study protocol, case report form, statistical analysis plan.
• Work as a member of the joint Sobi and CRO Clinical Team to establish, communicate and deliver on a clinical data handling strategy documented in a Data Management Plan.
• Ensure data delivered to Sobi is in accordance with regulatory requirements and Sobi standards.
• Participates in regulatory and Sponsor audits for assigned study.
• Provide a level of expertise in data management overall within Sobi and contribute to developing internal DM processes and SOPs.

• Leadership and project coordination of all data management activities in project/study from protocol development to submission.
• Responsibility for quality and location of Sobi’s clinical data.
• Support clinical study teams through the evaluation of CROs during the outsourcing process, ensuring that the selected CROs DM processes are in agreement with regulatory requirements and Sobi standards
• Input to relevant strategic study documents i.e. study protocol, case report form, statistical analysis plan
• Work as a member of the joint Sobi and CRO Clinical Team to establish, communicate and deliver on a clinical data handling strategy documented in a Data Management Plan.
• Ensure data delivered to Sobi is in accordance with regulatory requirements and Sobi standards.
• Provide a level of expertise in data management overall within Sobi and contribute to developing internal DM processes and SOPs.

• General support to the Pharmacovigilance department.
• Collect and review Adverse Drug Reactions (ADR)/Adverse Events.
• Duplicate check of ADR and SAE in the internal safety database.
• Archiving of Pharmacovigilance documents.
• Writing and review of SOPs.

• Provide Clinical Management support to the Clinical operations team and /or study project, Clinical Data Management team and Biostatistics team.

• Participates in the review of clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).

• Develops the Data Management Plan (DMP), maintains the DMP throughout the lifecycle of study project and ensures the DMP is followed according to study design and requirements.

• Develop Case Report Form (CRF), electronic and/or paper.

• Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and Data Validations.

• Lead EDC database (DB) specification process.

• Develops Data Transfer Agreement(s) (DTAs) between external data vendors or core labs and IRW.

• Reconcile Electronic Data Transfers from vendors to sponsor and/ or IRW.

• Develop test scripts and execution logs for User Acceptance Testing (UAT).

• Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.

• Maintenance/Tracking of EDC user management and other clinical databases across allocated clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.

• Perform EDC training of EDC users and create user guides.

• Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to data reconciliation and/or coding.

• Assist in defining and/or creation of data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.

• Coordinating the archiving of the study databases and related documents.

• Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.

• Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.

• Assist and provide input into study and project level data analysis plan.

• Coordinate and communicate with DB vendors on consistent basis to address clinical team's requests, project plans, and/or eCRF development activities.

• Collaborate with IT and implementation team(s) to address clinical application requests and/or changes to clinical database systems.

• Participates in the preparation and presentation of data, when applicable.

• Ensures data system compliance by following the established guidelines of national and international regulatory authorities.

• Participate in the conference calls and/or meetings with vendors.

• Act as Project Manager for projects, when Data Management is the main service to be provided.

• Coordinate the interaction with Biostatisticians and Biostatic vendors.

• Coordinate the development and implementation of ePRO solutions in projects.

•Contribute to the development of the Data Management and Biostatistics sections of proposals.

• Participate and contribute in customer meetings/sales activities.

• Develop SOPs for Data Management ensuring IRW processes and systems are up to date and compliant with applicable requirements.

• Participate in audits and inspections.

• Take on any level activity consistent with current or past experience in support of study delivery or delivery of other IRW goals.

• Conduct study start up activities, like Study design and Defining Sites, investigators and patients, Creating.

• CRF Designing, Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry, Generating and Testing data entry screens and validate the range, format, date, missing fields.

• Generating and testing Data Validation and Derivation procedures.

• Writing edit checks or validation procedures using ranges provided or in accordance with the protocol.

• Performing User Acceptance Testing (UAT), Test and execute validation procedures (Both single and batch validation)

• Review Case Report Forms (CRFs) generated from clinical trials for completeness and accuracy using Edit’s CRF listings, manual review and other appropriate guidelines.

• Query Management & Discrepancy management: Generating queries based on validation checks to clarify and improve the quality of the data.

• Creating DCFs and maintaining Discrepancies, resolving queries and updating the database.

• Review of un-resolved discrepancies, raise manual discrepancies wherever required and close where appropriate, Reviewing clinical data as per SOP, protocol, and study specific guidelines, Knowledge of Data Extract and SAS extract views.

• Commonly performed the following data related activities: CRF tracking, reviewing, validation, updating, SAE reconciliation, lab data reconciliation.

• Complete DB ‘pre-lock’ checklist; verify that all queries have been received from the sites and resolved.

• Lead Responsibility: Team management, client orientation, work allotment to the team & training the team members.

• Data entry in RDC and Discrepancy Management in RDC.

• Generating and testing Data Validation and Derivation procedures.

• Writing edit checks or validation procedures using ranges provided or in accordance with the protocol.

• Performing User Acceptance Testing (UAT), Test and execute validation procedures (Both single and batch validation)

• Query Management & Discrepancy management, Generating queries based on validation checks to clarify and improve the quality of the data.

• Creating DCFs and maintaining Discrepancies, resolving queries and updating the database.

• Review of un-resolved discrepancies, raise manual discrepancies wherever required and close where appropriate, Reviewing clinical data as per SOP, protocol, and study specific guidelines.

• Complete DB ‘pre-lock’ checklist; verify that all queries have been received from the sites and resolved.