Deepak Patil

• Interpret clinical study protocol and provide inputs to relevant stakeholders/sponsors.
• Designing Phase 1 to Phase 3 clinical trials based on clinical study protocol which includes various therapeutic areas like Neurology, Oncology, Cardiovascular.
• Managing study migration activities.
• Involved in creation and maintenance of training material, process trainings and associate mentoring.
• Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed
• Active hands-on Medidata RAVE Architect database.
• Maintains proficiency in Data Management systems and processes through regular training.
• Managed studies in setup phase. Good working knowledge of Clinical Trials data and proficiency in Medidata Rave.
• Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
• Perform post-migration testing on screens, edit checks, matrices and role changes as required.
• Reviews database design specifications (including configuration, data structures, annotated eCRFs).
• Designs and/or reviews eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design.
• Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS.
• Creates, updates and reviews study-specific documents such as eCRF DMP, eCRF Completion Guidelines.

• IRPC Tool
• To identify potential Adverse Event, Medical Information request and Product Complaint.
• To process non-Phonic documents into Intake Functional Records (IFRs).
• To generate the IFRs: MIR, PCM, AER, Referrals.
• To update the contact details.
• To assign the IFRs to respective teams for further processing.

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• EPIC: eTMF:
• Performs approval/s, approval with correction and rejection/s of Electronic Submissions workflow/s via Amgen’s TMF document management system according to SOPs and RIM Approval Workflow Checklist.
• · Maintains full understanding of study documentation properties in order to perform proper execution of clinical documentation activities.
• · Tracks and follows upon document/s discrepancies.
• · Communicates document/s, system, and hardware issues to the support team/s.
• · Escalate/s unresolved issues appropriately to TCS Team Lead and Client Support Team.
• · Provides support during internal and external inspection/s, including FDA audit/s.

• Reviewed clinical protocols and developed data management plans to ensure accuracy of collected information.
• Developed and tested edit checks for data entry, database development, and report generation.
• Performed validation checks on source documents to ensure accuracy of entered data into the database.
• Coordinated with clinical staff to resolve discrepancies in data entries.
• Conducted periodic audits of clinical sites to assess adherence to protocol requirements including data entry procedures.
• Performed reconciliation between source documents and EDC systems in order to identify any discrepancies or inconsistencies .
• · Managed studies in setup, conduct phase. Good working knowledge of Clinical Trials data and proficiency in Medidata Rave.
• · Handled query management which involves: Raising manual queries, closing answered queries.
• Responsible for reconciliation activities such as SAE reconciliation.
• Creation and maintenance of various study data reports including Query reports, Pages overdue reports etc.
• Discrepancy Management by analyzing the patient data linked in the database RAVE and manual query generation–reviewing answered and closing queries. To resolve issues from various stakeholders including SDM. Sending Discrepancies to sites and update the database after getting resolution from sites. Sending discrepancies to sites to either confirm or change the data for data consistency.
• Manual checks preparation to clean the clinical data thoroughly. Processing Study specific manual listings and raising queries in the database to ensure the patient data as clean.
• Science & Safety tracker review-To review science queries raise them in database and take science confirmation to close them.
• · Lab Data Reconciliation-Lab ranges entry and updating. To resolve various Lab issues by sending reports (MLN, MLR, Clear reports & Unit range mismatch) to sites, else raising queries in database for discrepant lab data. Data Mining Report generation and processing standard and study specific reports (MLN, MLR, DLR, Spotfire and J-Review).
• To resolve issues from monitors, SDM or Science through e-mails.
• Sending monthly metrics to Team leads or Group leads.
• Weekly QC of all the study activities. Validation of PD24 Forms and Entry and Verification of ranges and units. Handling and archivingPD24forms.
• Ensure review of DM deliverables to ensure the final quality of the deliverables.