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PROGRAM MGR, CLINICAL DATA MGMT
Job Title: PROGRAM MGR, CLINICAL DATA MGMT
Job Code: 1852
Job Level: 76
Revised Date: 08/01/2017
Job Family: JF 05
The Program Manager, Clinical Data Management independently oversees data management operations for an assigned CRU or department and serves as a leadership resource in the day-to-day data management operations for that program area. Ensures that projects are completed in accordance with the applicable regulatory requirements as well as the established budget, timelines, and sponsor specifications. 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. 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.
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.
Participates in review and provides input in writing proposals and grant applications.
Analyzes and proposes best practices for implementing and conducting project activities.
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.
Oversees forecasting and resourcing for program area.
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.
Required Qualifications at this Level
Requires a Bachelor's degree in a related field; Master's degree preferred.
6 years directly related data management experience to include at least 2 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
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.
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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.