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DIR, CLINICAL TRIALS OPERATIONS

Job Title: DIR, CLINICAL TRIALS OPERATIONS
Job Code: 2307
FLSA: E
Job Level: 98
Revised Date: 02/01/2022
Job Family: JF 05

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Occupational Summary

Direct a variety of complex and independent activities involved in administrative oversight of the clinical trials group; establish work procedures and resolve problems that may occur between various projects and workgroups.

Work Performed

Develop and maintain liaison with clinical trials participants including, but not limited to, researchers, clinicians, university administration, Food and Drug Administration, industry sponsors of research and other to manage activities and facilitate communications; prioritize new projects and maintain current sponsor relationships to include clinical trials outside the United States.

Coordinate, through accountable support personnel, the establishment of clinical trials schedules, task assignments and allocation of manpower and equipment to ensure conformance with specified objectives. Perform development and fundraising activities for the clinical trials group.

Develop operating policies and procedures for Clinical Trials Operations; conduct meetings with subordinates to ensure compliance with established practices, to implement new policies and to keep employees abreast of current changes and standards.

Manage automated systems as appropriate to support needs of the Clinical Trials Operations.

Prepare reports and analyses reflecting progress, adverse trends and appropriate recommendations or conclusions.

Direct various personnel functions including, but not limited to, hiring, merit recommendations, promotions, transfers and vacation schedules.

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

Education/Training

Work requires a Bachelor's degree

Experience

Ten years of relevant experience to include 7 years in leadership roles.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills

N/A


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.