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MANAGER, CLINICAL DATA OPERATIONS
Job Title: MANAGER, CLINICAL DATA OPERATIONS
Job Code: 2337
FLSA: E
Job Level: 87
Revised Date: 03/01/2005
Job Family: JF 05
Occupational Summary
The Manager, Clinical Data Operations independently oversees data management informatics operations and personnel for the department. This includes clinical trial data management operations and associated technology and standards implementations.
Work Performed
ADMINISTRATIVE MANAGEMENT
Ensure appropriate department infrastructure and systems are in place to support work, including: development and maintenance of quality systems, work processes, position descriptions, performance management and processes compliant with regulatory requirements.
Oversee department managers in performance management process including candidate selection, hiring, coaching, performance management, disciplinary action and termination, grievance/termination issues.
Analyze department forecasting, resources and utilization, and coordinate resources accordingly.
Manage Clinical Data Integration activities and staff across multiple therapeutic areas and/or functional sub groups.
PROJECT MANAGEMENT
Develop new business for CDI aligned with strategic plan and therapeutic area development.
Take leadership role in industry initiatives, for example: technical and process standards development, professional society administration, industry related certification programs and conference planning and delivery.
Oversee clinical database systems implementation, migration and validation.
Consult with other organizations on data management and integration, related regulations, and implementation of industry standards and best practices.
Consult with vendors developing software supporting data collection, management and integration.
Manage internal and external customer expectations.
TECHNICAL
Perform technical and business analyst activities for developing new data management platforms and modules to be used within CDI and across industry.
Responsible for business development activities such as presentations to prospective sponsors, development of scope of work and cost estimates across multiple therapeutic areas.
TRAINING
Maintains skills at the Manager, Clinical Data Operations level.
Presents information from external training sessions and conferences.
Required Qualifications at this Level
Education/Training
Bachelors degree in a related field, Masters degree is preferred
Experience
Minimum of 8 years of directly related data management experience. Experience managing department subgroups, functional or therapeutic areas, including oversight of management personnel are highly valued.
Skills
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.
