MANAGER, CLINICAL TRIALS OPERATIONS
MANAGER, CLINICAL TRIALS OPERATIONS
DCRI - Project Management
Manage and direct the efforts of a designated group of project leadersin order to ensure effective planning, oversight and coordination ofclinical research projects. Ensure appropriate utilization of projectmanagement tools and effective coordination of cross-functional projectteams. Responsible for monitoring the progress/performance of allprojects to include quality of services provided, timeliness ofdeliverables, compliance with regulatory requirements, and adherence tofinancial targets. Facilitate the training and career development ofProject Leaders. Determine project specifications and match ProjectLeaders to projects based on background, interest and availability.
Manage and direct the efforts of project leaders and recommendpersonnel actions including, but not limited to, hiring, performancemanagement, scheduling and work assignments, disciplinary action,promotions, and transfers.Define and communicate job descriptions, core competencies, andperformance standards and expectations. Develop and implement reward and recognition programs in order toachieve optimal employee satisfaction and retention. Coordinate regular staff meetings and ensure staff are kept abreast ofdepartmental and organizational activities, goals, and policies.Develop and implement orientation programs for new employees as wellas ongoing training, continuing education, and professional development.Establish accurate and consistent productivity expectations and reviseas needed. Make recommendations regarding staffing requirements tomeet departmental needs and achieve maximum productivity.
Determine resource requirements for project leadership functionalgroup and ensure efficient use of resources and adherence to budgetarytargets. Prepare budgetary forecasts for functional group expenses(operating and capital) on an annual basis. Monitor expenditure ofbudgeted funds and provide justification of variances.Ensure appropriate involvement and input of project leaders in thedevelopment and negotiation of trial budgets and contracts. Monitor expenditure of funds relative to budgetary targets for alltrials on an ongoing basis. Ensure that variances are identified andcommunicated to appropriate personnel in a timely manner. Facilitate efforts to implement appropriate interventions. Identify actual orprojected variances and advise Director as appropriate.Provide input to the Chief Financial Officer regarding financial information required by project leaders in order to effectively monitorfinancial performance of trials. Participate in and facilitate effortsto ensure that all trial related expenses are accurately andappropriately recorded in a timely manner.
Identify operational problems, issues, obstacles, and barriers acrossall projects based on input from projects leaders, PI's, project team members, and sponsors; communicate patterns and trends to Director of functional group staff as appropriate; and participate in and supportefforts to develop and implement process/system improvements.Oversee efforts of project leaders to develop and communicateappropriate project plans and timelines for all trial activities. Monitor progress of all trials on an ongoing basis relative toestablished timelines and key milestones. Ensure that delays areidentified and communicated to PI's, Director and functional groupstaff in a timely manner. Participate in and facilitate efforts toimplement appropriate interventions across functional groups in orderto meet timelines. Work with Strategic Planning & Development and PI's to identifyproject leadership resources required for each trial and ensureappropriate assignment/availability of staff.Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of workbeing performed by individuals assigned to this classification.This is not intended to be an exhaustive list of all responsibilitiesand 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 Employercommitted to providing employment opportunity without regard to anindividual'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 mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Bachelor's degree in nursing, pharmacy or other allied health carediscipline 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 whopossess a minimum of 10 years directly related experience and extremelystrong clinical knowledge.Prefer a Master's degree or other post-graduate training in a clinicaldiscipline or business/health care administration (MSN, PharmD, PhD,MD, MBA, MHA, MPH).
7 years of experience in clinical trial operations in an academicmedical 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 apersonnel management capacity (of professional/ technical/ clinicalstaff).Strongly prefer experience in a variety of therapeutic areas and inmanaging 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.