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CLINICAL DATA MANAGEMENT, MANAGER
Job Title: CLINICAL DATA MANAGEMENT, MANAGER
Job Code: 1336
FLSA: E
Job Level: 78
Revised Date: 01/08/2024
Job Family: JF 05
Occupational Summary
Responsible to the Research Practice Manager (RPM) for oversight of clinical research data management for the unit. Assists the RPM in the day to day management of CRU operations and people. Ensures that clinical research professionals and investigators are appropriately trained and performing collection, compilation, documentation, and analysis of clinical research data activities in concordance with regulatory and institutional policies and standards. Assists in providing operational and study conduct metrics and reports to RPM.
Work Performed
Research Operations
Supervises and provides guidance for the studies within the CRU as it relates to contracts and agreements, regulatory and institutional policies and processes, and study level documentation for clinical research data.
Directs teams to appropriate Duke offices and ensures compliance with institutional policy. Ensures that key personnel are properly trained and document training according to institutional and regulatory policies in a timely fashion.
Develops, supervises adherence to, and trains in the use and development of research and CRU SOPs.
Prepares for and leads effective facilitation of multidisciplinary meetings in order to achieve objectives. Follows up on action items when necessary. Ensures good communication within the unit, including mentoring staff to improve communication strategies.
Safety and Ethics
Monitors compliance with institutional requirements and, provides guidance to the CRU in relation to preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies.
Data
Oversees adherence with Institutional and CRU policies and best practices regarding data analysis, Coordinates with statistical collaborators to ensure support and oversight for studies within the unit.
Monitors compliance with institutional requirements and provides guidance pertaining to quality data collection and capture, data security, and data flow plans.
Supervises and reviews data management and cleaning practices and provides guidance for teams within the CRU. Collaborates with study teams and investigators throughout the unit to develop and implement appropriate standards for consistency within data management across the CRU.
Performs data audits on specific studies and provides corrective action as needed.
Guides CRU to institutional resources as necessary for study compliance with data processes and policies (e.g., ISO, IRB).
Monitors compliance with federal and institutional requirements related to data sharing. Builds process to ensure timely deposit of data following publication or study end.
Monitors compliance with institutional, federal, and data provider requirements related to the de-identification of research data. Provides guidance on resources related to de-identification, and may serve as a Federated Honest Broker for the CRU.
Assists with and provides guidance on the implementation of new technologies across the CRU.
Monitors adherence to best practice and institutional goals related to return of study results. Provides consult and guidance to study teams across the CRU on planning, budgeting, and resources to share study results with participants and providers as appropriate.
Supervises and provides guidance for the studies within the CRU on reporting study metrics and progress. Collaborates with CRU biostatistical support to provide education and support to teams.
Monitors compliance with regulations and best practices related to EDC validation and testing. Provides guidance to the CRU on 21 CFR Part 11 or other federal, contractual, or institutional requirements related to testing and validation of EDCs. Reviews documents and provides input for training and ongoing compliance.
Scientific Concepts
Supervises and provides guidance for the studies within the CRU as it relates to Open Science initiative and FAIR data practices.
Assists RPM as needed with ensuring appropriate documentation of scientific review processes, including decisions made by scientific reviewers/review committees.
Site and Study Management
Works with financial staff in developing and negotiating budgets with sponsors. Acts as the primary contact during study startup and intervenes when study teams have a conflict with sponsors and/or CROs.
Ensures that studies within the CRU are conducted in compliance with institutional requirements and policies related to data. May serve as the CRU point of contact for the Duke Research Data Lifecycle plan.
Serves as an expert resource to clinical research professionals and outside agencies with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory concerns regarding data.
Monitors compliance with institutional requirements and, provides guidance to ensure that studies are closed according to best practices and guidelines.
Leadership and professionalism
Evaluates and implements professional development and/or training programs offered through DOCR (e.g., Research Professionals Network (RPN), Research Wednesdays) to encourage staff retention, continuous improvement, and development. Creates a team environment with a culture that fosters communication. Communicates effectively across the CRU about new policies, regulatory updates, and institutional SOP changes.
Keeps current with research updates and oversees implementation of new policies and regulations among staff members. Contributes to and represents the institution in internal and external groups related to clinical research data (e.g., institutional initiatives or committees).
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience, leadership, and actively facilitates change within CRU.
Uses advanced subject matter expertise in clinical research data management to solve complex problems and develop and implement solutions to improve the research process.
Required Qualifications at this Level
Education/Training
Work requires completion of a Bachelor's degree.
Experience
Work requires a minimum of six years of related experience, with at least four years in a research setting. A Master's degree may substitute for two years of related experience.
Skills
Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
