POSITION TITLE:Lead Clinical Data Manager
REPORTS TO:Manager or Director level Data Management or Designee
Lead Clinical Data Manager position is to manage all data management (DM) tasks for multiple projects from project start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Manages DM-related aspects of the projectRepresents DM as the functional lead at internal and sponsor project team meetingsProvides proactive, timely communication of project status, data trends and issue resolution with internal team and SponsorDevelops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and SponsorAssumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelinesWorks with DM program and/or administrative manager to provide resource and budget projectionsDiscusses roadblocks and proposed solutions for completing project objectives in a timely mannerPresents EDC and/or CRF completion at Investigator MeetingsParticipates in regulatory and Sponsor audits for assigned study Oversees daily team member activitiesServes as a Data Management team leaderProvides training of DM staff on project specific processesAssures project activities are performed within budget and according to expected timelines and meet high quality standardsReviews DM team member activities and deliverables to ensure plans and processes are followedOversees the DM project team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans including but not limited to:Discrepancy managementData Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendorsInvestigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviews Oversees Clinical Data Management System Development and Maintenance:Implements DM strategy on the project based on scope of services and as laid out by DM managementCoordinates with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM timelines for startup and mid-study updates including the development, testing and implementation of all data capture toolsCoordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelinesCoordinates with the Technical Design and Clinical Programming team and/or 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirementsCoordinates with the EDC programmers and/or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO) and electronic clinical reported outcomes (eCOA) as required per the scope of work Facilitates project team and Sponsor reviews of system documents including but not limited to Time and Events Schedule, CRFs, Edit Checks, revision specificationsConsolidates reviewer comments from internal team/sponsor and collaborates with the project and Clinical Programming team, as required, for revisionsCoordinates with the project team as well as the Technical Design and Clinical programming team to manage post go-live EDC modifications Oversees System and Data Listing Testing Activities:Coordinates testing activities for the EDC technologies per scope of servicesPerforms testing for EDC systems as required per scope of services and standard operating proceduresVerifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requestsProvides feedback to the other project team members and managers to improve the deliverables Develops, Maintains and Archives DM Project Documentation including:Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as required.Data review listing specificationsDatabase Design Documents, Edit Specifications, Reconciliation guidelines, and Report specifications.Database lock documentation Represents Data Management at Bid Defense Meetings (BDM)Prepares project-specific slide presentation from DM template functional slides in collaboration with DM managementParticipates in BDM preparation meetings including discussing overall DM strategy collaborating with Manager as requiredPresents DM slides at BDM and constructively participates in discussion Continuous ImprovementRecommends improvements to existing standards including processes, CRFs, data listing reports and document templatesKNOWLEDGE, SKILLS AND ABILITIES:
Team player with ability to learn new skills, tasks and technologies and teach others Ability to work well with technical and clinical team members and collaborate with entire clinical team (CRAs, Safety, Biostatistics, etc.) Ability to communicate technical issues to non-DM team members and Sponsor Ability to maintain positive and open relations with internal, sponsor, and vendor team members Ability to facilitate team meetings Knowledge of clinical trials concepts Ability to create detailed DM project instructions and documents (CRF Completion Guidelines, database design documents, edit check specifications, Data Review Plan, etc.) Proficiency with clinical trial Electronic Data Capture (EDC) systems (preferred systems are InForm and Rave) Proficiency with IQVIA Biotech SOPs, WPs for general and DM operations Efficient with organizational skills to meet established timelines Organized and thorough with attention to details Excellent verbal, written and listening communications skills Effective interpersonal skills including ability to accept constructive feedback Effective logical thinking ability regarding problem-solving skills Proficiency in computer applications and time management tools (e.g., MS Office)CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Very little physical effort required to perform normal job duties (unless otherwise indicated) Occasional travel for Bid Defense Meetings, Investigator Meetings, client face-to-face meetings, user group meetings or training courses. Travel not anticipated to exceed 1-2 times per quarter.MINIMUM RECRUITMENT STANDARDS:
Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle Equivalent combination of education, training and experience#LI-SA3
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