Manager, Clinical Trial Operations (Office Based) - NCR
Novella Clinical seeking Manager, Clinical Trials Operations (office based in Raleigh-Durham) with multi-therapeutic background:
Manage and direct the efforts of a designatedgroup of project leaders in order to ensure effective planning, oversight andcoordination of clinical research projects. Ensure appropriate utilization ofproject management tools and effective coordination of cross-functional projectteams. Responsible for monitoring the progress/performance of all projects toinclude quality of provided services, timeliness of deliverables, compliancewith regulatory requirements, and adherence to financial targets. Facilitatethe training and career development of Project Leaders. Determine projectspecifications and match Project Leaders to projects based on background,interest and availability.
Manage and direct the efforts of project leadersand 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, corecompetencies, and performance standards and expectations. Develop and implementreward and recognition programs in order to achieve optimal employeesatisfaction and retention. Coordinate regular staff meetings and ensure staffis kept abreast of departmental and organizational activities, goals, andpolicies. Develop and implement orientation programs for new employees as wellas ongoing training, continuing education, and professional development.Establish accurate and consistent productivity expectations and revise asneeded. Make recommendations regarding staffing requirements to meetdepartmental needs and achieve maximum productivity.
Determine resource requirements for projectleadership functional group and ensure efficient use of resources and adherenceto budgetary targets. Prepare budgetary forecasts for functional group expenses(operating and capital) on an annual basis. Monitor expenditure of budgetedfunds and provide justification of variances. Ensure appropriate involvementand input of project leaders in the development and negotiation of trialbudgets and contracts. Monitor expenditure of funds relative to budgetarytargets for all trials on an ongoing basis. Ensure that variances areidentified and communicated 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 theChief Financial Officer regarding financial information required by projectleaders in order to effectively monitor financial performance of trials.Participate in and facilitate efforts to ensure that all trial related expensesare accurately and appropriately recorded in a timely manner.
Identify operational problems, issues, obstacles,and barriers across all projects based on input from projects leaders, PL’s,project team members, and sponsors; communicate patterns and trends to Directorfunctional group staff as appropriate; and participate in and support effortsto develop and implement process/system improvements. Oversee efforts ofproject leaders to develop and communicate appropriate project plans andtimelines for all trial activities. Monitor progress of all trials on anongoing basis relative to established timelines and key milestones. Ensure thatdelays are identified and communicated to PL’s, Director and functional groupstaff in a timely manner. Participate in and facilitate efforts to implementappropriate interventions across functional groups in order to meet timelines.Work with Strategic Planning & Development and PL’s to identify projectleadership resources required for each trial and ensure appropriateassignment/availability of staff. Perform other related duties incidental tothe work described herein. The above statements describe the general nature andlevel of work being performed by individuals assigned to this classification.This is not intended to be an exhaustive list of all responsibilities andduties required of personnel so classified.
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.
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