MANAGER, CLINICAL TRIALS OPERATIONS, DCRI Gov't & Networks
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.
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 provided services, 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.
- 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 is 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.
- 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.
- 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.
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).
Seven 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
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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.