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Onebridge is a Consulting firm with an HQ in Indianapolis, and clients dispersed throughout the United States and beyond. We have an exciting opportunity with a Global Client for a highly skilled Clinical Data Manager.
This is a full-time salaried role with our direct client. This position is 100% remote for a candidate based in the United States.
Clinical Data Manager | About You
As a Clinical Data Manager, you will lead, plan, and execute all data management activities for assigned projects. You are ensuring the team focuses on data integrity, validity, and reliability through standard processes, sponsor guidelines, industry best practices, and regulatory standards.
Clinical Data Manager | Day-to-Day
- Serve as the Lead Data Manager and primary contact responsible for overseeing day-to-day data management activities from study start-up through final database lock, including, but not limited to:
- Creation and maintenance of the Data Management Plan.
- Development and design of Case Report Forms (CRFs).
- Develop Database Build specifications and coordinate database build and testing activities with database programmers.
- 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.
- Oversee database lock and transfer process.
- Lead and participate in internal and sponsor meetings as required, working directly with to provide data management support.
- Ensure approved study documentation is maintained and properly stored in the trial master files.
- Act as a point of escalation for data-related issues and queries.
- Assist Clinical Project Manager in site management activities such as reviewing monitoring reports, tracking site visits, and communicating with monitors and sites.
- Maintain and track revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms.
Clinical Data Manager | Skills & Experience
- 7+ years of progressive Clinical Data Management or related clinical experience working for CRO's, Pharma, Med Device, or other clinical study organizations.
- Extensive experience managing clinical data in various phases (I-III) of clinical trials using EDC systems.
- Skilled in driving study data strategy from start-up design to completion, including the development of the data validation specification (DVS).
- Experienced in creating eCRF Completion Guidelines (CCG), EDC, SAE reconciliation guidelines and third-party (vendor) data reconciliations.
- Thorough understanding of FDA regulations.
- Self-motivated with crips and effective communication skills.
APPLICANTS MUST BE ELIGIBLE TO WORK WITHOUT SPONSORSHIP AND SHOULD BE LOCATED IN THE CONTINENTAL UNITED STATES.
100% Employee-Owned & Voted the #1 Best Place to Work in Indiana, 2021.
