MANAGER, CLINICAL TRIALS OPERATIONS
MANAGER, CLINICAL TRIALS OPERATIONS
DCRI - Project Management
Manage and direct the efforts of a designated group of project leaders in order to ensure effective planning, oversight and coordination of clinical research projects. Ensure appropriate utilization of project management tools and effective coordination of cross-functional project teams. Responsible for monitoring the progress/performance of all projects to include quality of services provided, timeliness of deliverables, compliance with regulatory requirements, and adherence to financial targets. Facilitate the training and career development of Project Leaders. Determine project specifications and match Project Leaders to projects based on background, interest and availability.
Personnel Management Manage and direct the efforts of project leaders and recommend personnel actions including, but not limited to, hiring, performance management, scheduling and work assignments, disciplinary action, promotions, and transfers. Define and communicate job descriptions, core competencies, and performance standards and expectations. Develop and implement reward and recognition programs in order to achieve optimal employee satisfaction and retention. Coordinate regular staff meetings and ensure staff are kept abreast of departmental and organizational activities, goals, and policies.
Develop and implement orientation programs for new employees as well as ongoing training, continuing education, and professional development. Establish accurate and consistent productivity expectations and revise as needed. Make recommendations regarding staffing requirements to meet departmental needs and achieve maximum productivity. Financial Management Determine resource requirements for project leadership functional group and ensure efficient use of resources and adherence to budgetary targets. Prepare budgetary forecasts for functional group expenses (operating and capital) on an annual basis. Monitor expenditure of budgeted funds and provide justification of variances. Ensure appropriate involvement and input of project leaders in the development and negotiation of trial budgets and contracts. Monitor expenditure of funds relative to budgetary targets for all trials on an ongoing basis. Ensure that variances are identified and communicated to appropriate personnel in a timely manner.
Facilitate efforts to implement appropriate interventions. Identify actual or projected variances and advise Director as appropriate. Provide input to the Chief Financial Officer regarding financial information required by project leaders in order to effectively monitor financial performance of trials. Participate in and facilitate efforts to ensure that all trial related expenses are accurately and appropriately recorded in a timely manner. Project/Operations Management Identify operational problems, issues, obstacles, and barriers across all projects based on input from projects leaders, PI's, project team members, and sponsors; communicate patterns and trends to Director functional group staff as appropriate; and participate in and support efforts to develop and implement process/system improvements.
Oversee efforts of project leaders to develop and communicate appropriate project plans and timelines for all trial activities. Monitor progress of all trials on an ongoing basis relative to established timelines and key milestones. Ensure that delays are identified and communicated to PI's, Director and functional group staff in a timely manner. Participate in and facilitate efforts to implement appropriate interventions across functional groups in order to meet timelines. Work with Strategic Planning & Development and PI's to identify project leadership resources required for each trial and ensure appropriate assignment/availability of staff. 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.
1746 MANAGER, CLINICAL TRIALS OPERATIONS
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. 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.
Bachelor's degree in nursing, pharmacy or other allied health care discipline including appropriate certification/licensure (i.e., RN, PA, or RPh) required. OR Bachelor's degree in a life science field (i.e., biology, chemistry, zoology, etc.) acceptable for those candidates who possess a minimum of 10 years directly related experience and extremely strong clinical knowledge. Prefer a Master's degree or other post-graduate training in a clinical discipline or business/health care administration (MSN, PharmD, PhD, MD, MBA, MHA, MPH).
7 years of experience in clinical trial operations in an academic medical center, or in the pharmaceutical, medical device, biotechnology, or contract research industry. 3-5 years in a project management capacity and 1-2 years in a personnel management capacity (of professional/ technical/ clinical staff). Strongly prefer experience in a variety of therapeutic areas and in managing large international trials. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.