Clinical Data Management, Manager

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

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 Brain Tumor Center (BTC) 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 – 20% Effort

• Supervises and provides guidance for the studies within the BTC 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 BTC 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 – 15% Effort

Monitors compliance with institutional requirements and provides guidance to the BTC in relation to preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies.

Data – 30% Effort

• Oversees adherence with Institutional and BTC 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 practice and provides guidance for teams within the BTC. Collaborates with study teams and investigators throughout the unit to develop and implement appropriate standards for consistency within data management across the BTC.

• Performs data audits on specific studies and provides corrective action as needed.

• Guides BTC 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 BTC.

• Assists with and provides guidance on the implementation of new technologies across the BTC.

• Monitors adherence to best practice and institutional goals related to return of study results. Provides consultation and guidance to study teams across the BTC on planning, budgeting, and resources to share study results with participants and providers as appropriate.

• Supervises and provides guidance for the studies within the BTC on reporting study metrics and progress. Collaborates with BTC 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 BTC 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 – 5% Effort

• Supervises and provides guidance for the studies within the BTC 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 – 10% Effort

• 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 BTC are conducted in compliance with institutional requirements and policies related to data. May serve as the BTC 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 – 20% Effort

• 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 BTC 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 BTC.

• Uses advanced subject matter expertise in clinical research data management to solve complex problems and develop and implement solutions to improve the research process.

And other work as assigned. The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.  Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Minimum Qualifications

Education

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.

Preferences

• The ideal candidate will have an advanced degree (e.g. Master’s, PhD) in a scientific/medical or related field (e.g. biology, chemistry, biostatistics, bioinformatics, computational biology) with additional experience in a research setting totaling 6 years of experience (i.e. Master’s + 4 years or PhD + 1 year).

• The ideal candidate will have experience, preferably in a leading/independent role, in the collection and management of clinical data, including experience with regulatory, privacy and compliance aspects.

• The ideal candidate will be moderately to expertly experienced with database and data management software, including Excel and/or clinical data software (e.g. Advarra Oncore, Epic, REDCap, Rave,  etc).

• Experience with large/complex datasets, and familiarity with R, Python/Jupyter would be beneficial but not required.

• Having experience leading/managing a team is a plus.

Job Code: 00001336 CLINICAL DATA MANAGEMENT, MANAGER
Job Level: 78

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