Experience

PVR Technologies Inc

• United States
• Staffing and Recruiting
• 1 - 100 Employee

• lead clinical data manager

  • Oct 2018 - Present

  Responsibilities include leading internal and outsourced Clinical Data Management activities and are accountable for data quality, and consistency at Database Lock.Communicating with Vendors regarding the vendor reconciliation process and the discrepancies.Act as a primary person of contact of Data management in meetings with the other stakeholders like Clinical, Safety and Biostatisticians.Lead in the development of a eCRF and Data Management Plan (DMP), CRF flow, data queries, manual checks, and data listings needed to facilitate data cleaning in accordance to our Data Review Plan Maintain good inter-team communication with all the other participating teams of the study.Ensure all the assigned projects are in accordance to timelines and deliverables.Provide Quality Control on deliverables developed by other team members.Review the study protocol and design CRF with project team for data acquisition and data entryDevelop and review Data management plan and Data Validation PlanDocument all the clinical data management process and procedures including CRF completion Guidelines, DMP, Data Verification documents and data transfer agreementPerforming all the data cleaning activities of ongoing and conduct studies.Help in updating standard operating procedure as needed.Review and provide feedback to the clinical team on all the documentation regarding the studies.Make sure all the Data management process are in accordance with ICH GCP guidelines and standardsCheck all the SAE are reported and perform the SAE reconciliationPerform data freezing, database lock activities including QC of database.Perform Quality Control of data by manual ReviewsCreate Test Cases and perform UAT of data captured and Data Management SystemCreate and execute Queries in EDC system to be resolved at the investigation site. Show less

• Senior Clinical Data Manager

  • Aug 2016 - Oct 2018

  Oversee all DM activities internally, coordinating with the CRO, external vendors.Generated the project specific timelines, deliverables and attained with at most quality.Developed Data Management plan, Data transfer agreements, CRF Completion guidelines and other DM specific documents.Worked as a primary person from CDM in the meetings with Clinical, Safety and Biostatisticians.Involved in the training of internal team, CRA’s, CRO and vendors based on the project requirements.Created annotated CRF’s in compliance with CDASH standards.Performed clinical trial data management activities for Phases I to IV.Involved in creating Data validation plan including edit checks and Manual listings.Performed UAT and QC of data for several trials.Executed SAE reconciliation and external PK/PD vendor data reconciliation for several clinical trials.Reviewed data listings and performed QC of the data.Responsible for supporting database locking activities, including planning and executing listing reviews and identifying remaining clinical and monitoring tasks. Show less

• Clinical Data Manager

  • May 2013 - Jul 2016

  Reviewed clinical trial data according with Data Management Plans and applicable SOPs to identify erroneous, missing, incomplete, or implausible data.Coordinates work of other Clinical Data Management staff assigned to the project.Ensured the studies are conducted as per the protocol requirements, SOPs, ICH GCP and standard guidelines.Participated in the study set-up, UAT of EDC systems, edit/data validations checks, and programmed listing needed for data review and discrepancy management.Ensure the successful execution of data management elements of project plan. This includes monitoring tasks and managing timelines related to data management deliverables, database development and database snapshot & lock.Promptly reports SAEs and follow up to ensure all necessary documents have been submitted and accurate.Developed database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.Developed Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.Acted as a point of contact for external lab vendors for managing the external data loading issues.Developed test scripts and execution logs for User Acceptance Testing (UAT). Reviewed clinical research study protocols.Designing CRFsProviding feedback to the clinical team on protocol and CRF design.Developing of study documents like Data Validation Plan, CRF Filling Guidelines and Data Entry Guidelines etc.UAT Testing: Testing and executing Validation procedures.Generating queries to clarify and improve the quality of the data, resolve them or initiate their resolution either via research associate or directly with the investigational site.Performed Lab and SAE ReconciliationContributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study close-out. Show less