Everest Clinical Research

Manager

• Work with a Director and/or Senior Director of Clinical Data Management to manage clinical trial programs/projects from one or multiple clients.
• Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
• Manage client accounts and perform client relationship management.
• Function as a technical and operational leader, serve as a Principal level Lead Data Manager for individual clinical trials or a program of clinical trials, lead data management teams, interact with clients and/or Everest internal project leaders to plan and implement data management project plans, and generate and deliver quality data management deliverables.
• Mentor and develop staff members as well as team members supporting projects with oversight responsibilities.
• Review data management deliverables generated by the teams and provide review comments to ensure overall satisfactory team performance and quality delivery.
• Perform regular one-on-one meetings, performance reviews, and evaluation of staff members.
• Participate in data management project budget planning, tracking, and reporting.
• Develop and manage data management resource plans and perform ongoing assessment and control for the utilization of resources.
• Assist with integrating the operations of Clinical Data Management with the requirements of other functional service teams to assure cooperative realization of corporate objectives and to optimize the productivity and effectiveness of clinical data management.
• Assist with performing competitive benchmarking of clinical data operations to ensure that data management techniques and procedures used in the unit are the best in the class.
• Participate in the planning, development, and maintenance of Clinical Data Management governing documents in line with industry good data management practices in CRF design, database definition, data processing, and data management.
• Participate in, and contribute to, the corporate efforts in investigating, establishing, and implementing new and advanced systems, standards, and procedures to improve the effectiveness and efficiency of clinical data management.
• Contribute to organization development and growth by participating in the interview and evaluation process for job candidates.
• Assist in business development activities, including but not limited to, the following: provide cost estimates of data management services; participate in generation of project proposals and bid defense meetings; and participate in professional trade shows when required.

Manager, Clinical Data Management

Data Scientist

• Lead Data Management Activities, Perform Training and Client Relationship Management
• 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.
• Participate in project bid defense meeting when required.
• Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
• Provide training to new data management personnel on data management processes and procedures.
• Perform QC review of work performed by less experienced data management 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.
• Perform Third Party non-CRF data management activities.
• Review data, issue and resolve queries.
• Assist Investigative Site personnel with resolving queries.
• 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.

Manager, Clinical Data Management

Senior Clinical Data Manager