Prime Responsibilities Of A Clinical Data Manager While Conducting Clinical Trials

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial.

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As a Clinical Data Manager, you will be expected to:

  • Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
  • Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
  • Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
  • Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
  • Assist with study-level resource planning and management, including the review of team members’ timesheet reports.
  • Assist in performing client relationship management activities.
  • Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
  • Assist in generation of project Work Orders and Amendments.
  • Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
  • Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
  • Provide support to client audits and regulatory inspections. Follow up on audit findings.
  • Create and maintain clinical trial Data Management Study Binders. Perform Hands-on Data Management Activities
  • Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
  • Design and review Clinical Trial Source Document templates and completion instructions when required.
  • Develop and maintain data validation specifications.
  • Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.
  • Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).
  • Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
  • Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
  • Define and test edit checks
  • Perform data review and query generation/resolution
  • Track study progress and issue periodic status reports • Process/reconcile electronic data received from other data sources, e.g. CIMS, Safety database, labs, IRT
  • Oversee database lock and transfer process
  • Coordinate the day-day work of the Data Management staff assigned to the project
  • Train and mentor assigned employees on data management procedures and guidelines
  •  Participate/lead internal/sponsor meetings as required, working directly with the assigned project manager and team to provide data management support
  • Ensure approved study documentation is maintained and properly stored in the trial master files
  • Manage project resources per budget and within expected timeframes
  • Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and sponsors on data collection processes, tools and/or equipment as required
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  • Act as point of escalation for data related issues and queries
  • Independently make decisions for questions contained to their assigned projects
  • Escalate concepts to the Manager that may impact or benefit the rest of the department or other studies
  • Perform Third Party non-CRF data management activities.
  • Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
  • Ensure Data Management deliverables for projects assigned meet/exceed project/study team expectations regarding quality, time, and cost.
  • Serve as the subject matter expert on data collection strategy and handling of study data for assigned programs and effectively liaise with programming to ensure clinical databases are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission.
  • Proactively identify data management project issues, manage risks and alert Senior Department Management with a view to remedial action.
  • Interact/liaise with other departments to ensure a high level of client satisfaction through successful issue resolution and execution of projects.
  • Perform Serious Adverse Event reconciliation.
  • Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
  • Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.
  • Perform database soft-lock and hard lock activities.
  • Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.
  • Act as the primary data management contact, both external and internal, for projects
  • Ensure launch, delivery and completion of all Data Management procedures according to contractual agreement and relevant SOPs, guidelines and regulations
  • Monitor and communicate project progress to the customer and project team, including use of project status reports, and tracking tools/metrics
  • Manage changes of scope, budget, revenue recognition, and participation in internal project reviews.
  • Ensure consistency of process and quality across projects
  • Manage work assignment and delivery of project tasks to the off-shore data processing and programming team as required
  • Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals
  • Be willing to travel both domestically and internationally as necessary

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