Title: Sr. Clinical Data Manager
Company: Medical Device
Location: Minneapolis, MN
Type: Permanent Role
Notes: No Corp to Corp
- Leads aspects of data management including, but not limited to:
- Designing CRF's, CRF completion guidelines, database user requirements, technical requirements;
- Creating data management plans;
- Performing ongoing data review, medical coding, e.g., of adverse events, medical history; or concomitant medications;
- Coordinating and facilitating User Acceptance Testing (UAT);
- Reviewing protocol and clinical study reports for data management content;
- Creating and maintaining tools for efficient management of the project;
- Creating or reviewing all other data management-related study documents and validation efforts;
- Overseeing data validation efforts, including plan and report generation, staff training, validation oversight and corrections.
- Managing study records related to Data Management responsibilities for the Trial Master File.
- Develops, validates and maintains databases in accordance with customer and regulatory requirements
- Recommends solutions to internal project teams and RCRI clientele as necessary.
- Interprets and implements 21 CFR, Part 11 requirements.
- Participates in establishing and maintaining Clinical Trial Management (CTMS) and/or electronic regulatory binder features and functionality and new module features and functionality (e.g., safety, adjudication, device accountability, monitoring) standardization.
- Develops and maintains project timelines and budgets and reports any issues to project manager.
- Analyzes and reports all study issues to supervisor, project manager, and/or sponsor, as appropriate.
- Works with Biostatisticians and clinical project managers to define reports, edit checks, new database features, etc.
- Interacts with Biostatisticians and clinical project managers to further RCRI's use of database features and modules.
- Serves as database user expert.
- Ensures compliance with RCRI and applicable sponsor SOPs.
- Assists in the creation and management of internal training, data standardization and/or SOPs.
- Participates in client meetings, as necessary.
- Attends applicable internal and external training programs each year.
- Contributes to Business Development activities, as required, which may include, but not be limited to:
- Actively marketing RCRI data management services to current and potential clients;
- assisting in marketing efforts of RCRI services and database solutions to current and potential clients;
- assisting in the preparation of client proposals and work orders, and attending bid defense meetings.
- May perform dual roles as Project Manager, as necessary.
- Science, IS, health-related, or technical bachelor's degree.
- Minimum of five years of data management and/or clinical experience preferred with at least three specifically in data management.
- Excellent communication and interpersonal skills.
- Strong organizational skills.
- Ability to travel up to 20% time preferred.
- Experience with clinical systems, including data management, EDC, and Clinical Trial Management Systems (CTMS) experience is required.
- Database development and/or validation experience is required.
- Highly proficient with MS Office. Solid understanding of software capabilities and business applications.
- Ability to independently handle multiple tasks and prioritize with minimal oversight.