PROGRAM MGR, CLINICAL DATA MGMT
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
The Program Manager, Clinical Data Management independently oversee and support data management operations for the Departments of Surgery and Head & Neck Surgery data enterprise to include research, administrative, quality improvement, and health services research projects. Provide leadership, collaboration, and integration of data -related activities across the Department and Health System. Ensures appropriate use of project management and data management tools. Serves as a resource to data managers in troubleshooting project-related issues.
The Program Manager is responsible for and provides technical and management oversight for projects and departmental data portfolio. Manage a team of data, database, and clinical data repository staff. The Program Manager will oversee project management through supervision and mentoring of assigned data management staff to ensure that data is in compliance with applicable regulatory requirements and in accordance with sponsor specifications.
- Facilitates problem resolution and issues escalation across therapeutic area projects or program. Oversee design and implementation of data integration plans for complex projects; Identify process trends and improvements for efficiency
- Maintains a working knowledge of healthcare and research standards; provides leadership in choosing best practices for data management processes, including data integration models. May participate in business development activities, development of scope of work and cost estimates across multiple therapeutic areas.
- Perform technical and business analyst activities for developing new data management platforms; Provide leadership for defining data management project requirements and effective implementation options; Provide support for project management, reporting and analyses, multi-site academic collaborations and data sharing; Initiate and maintain inventory of Department of Surgery databases and establish centralized view of assets and resources; Ensure project completion in accordance with regulatory requirements, established budget, timelines, and sponsor specifications; Participate in project review and provide input inwritten proposals and grant applications with a data component; Identify, submit applications, and obtain external funding for data-related projects; Collaborate with and triage needs to Biostatistics & Bioinformatics, Grants, Clinical Operations, Performance Services, Information Technology, and Data Science teams.
- Develops complex project plans, such as integration of multiple data sources or migration of data between systems.
- Educates internal and external partners on Electronic Data Capture (EDC) and data surveillance activities.
- Provides direction and input in the development of operational plans for new data project proposals.
- Manages internal and external customer expectations.
- Oversees budgets of projects in their therapeutic areas and implements corrective action to maintain budget.
The Program Manager performs technical and business analyst activities for developing new data management platforms and modules to be used within clinical departments and across therapeutic areas. Provides the expertise and leadership for defining data management project requirements, considerations and effective implementation options utilizing novel or complex data systems and coordination of appropriate resources.
- Provides support for database creation, project management, reporting and analyses, IRB and data agreement, multi-site academic collaborations and data sharing.
- Identify, submit applications, and obtain external funding for unfunded data projects as opportunities arise.
- Oversees design and implementation of appropriate data integration plan for complex projects, including management of vendors. Obtains and analyzes user needs for business processes. Provides input for creation and maintenance of department work processes Identifies process trends across trials, underlying root causes and improvements for efficiency.
- May perform project leader role on data or stats only projects.
The Program Manager position may be responsible for managing staff with full authority for candidate selection, orientation, coaching, performance management and, when necessary, disciplinary action including termination.
- Coaches for successful completion of new tasks.
- Manages staff across a therapeutic area and/or functional sub-groups.
- Executes department strategic planning efforts and communications; may participate in development.
- Plans, coordinates, and allocates resources across multiple trials within their group. Participates in and facilitates data management and organizational improvement initiatives.
- Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requires a Bachelor's degree in a related field; Master's degree preferred.
Six years directly related data management experience to include at least two years of administrative, supervisory or project management experience. Experience managing multiple projects & teams and experience supervising staff, particularly departmental teams or sub-groups are highly valued. Certified Clinical Data Manager (CCDM) designation is strongly recommended. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.