Associate CEVA Manager - Research Triangle Park, NC

Location: MORRISVILLE, NC 27560 Job Category: Medical/Health Career Level: Experienced (Non-Manager) The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider.  We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else around the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar!! The Clinical Event Validation and Adjudication (CEVA) department is seeking an enthusiastic Associate CEVA Manager to join our team.  PURPOSEThe CEVA department creates, organizes, and manages Advisory Boards to review and ensure Drug Safety on clinical trials.  Serves as CEVA project manager, mentor and functional knowledge resource for Quintiles staff and clients on large, multi-service and/or multiple global clinical projects. Effectively and independently applies CEVA process knowledge in a leadership capacity. Promotes efficient execution of CEVA services in the areas of endpoint adjudication committee coordination, core laboratory coordination, DSMB administration and Steering Committee administration.  Responsible for the operational management of CEVA project teams, processes and procedures. Oversees and approves the design, direction and progress of all aspects of assigned projects. Ensures that assigned projects are completed on-time, within budget and according to quality standards. Regularly interfaces with clients, both internal and external.  Participates in departmental management initiatives as well as business development efforts.   RESPONSIBILITIES Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assigned projects; set up and maintain project materials such as project files, forms, templates, databases and workflow. Build a positive, collaborative team environment with project team members; provide training and mentoring for project team members and department staff; assist management with allocating resources to projects. Establish and maintain effective project communications by representing department at interdepartmental project team meetings, investigator meetings, and client meetings and by conducting productive internal department project team meetings; provide global coordination of departmental activities. Track financial status of assigned projects; assist overall project manager with clinical related change orders. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner; complete regulatory reports. Manage case follow-up and closure processes; process cases as needed. Assist senior leaders in managing department by identifying, developing and implementing new processes and systems designed to improve quality and efficiency, representing department at sales, marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions (WIs).   Four year degree in a medical, scientific or healthcare-related field.  AND Two years of experience independently leading and executing CEVA projects, including at least one year of experience successfully managing a major CEVA project (e.g. a large, global, multi-service and/or high profile project).   Or equivalent combination of education, training and experience, including (but not limited to): Nursing degree (RN) and at least two years of line management/team leadership experience.  OR Four year degree and at least two years of line management experience, preferably in a CRO setting.  OR At least four years of line management/team leadership/customer management experience in a medical, scientific or healthcare-related role, preferably in the area of managing clinical projects (e.g. experience as lead team member in CEVA, Safety, Data Management, Clinical).  OR Other comparable combination of education and experience, as well as demonstrated skills and ability to perform responsibilities attributed to this role.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Strong project management skills Strong organizational and multitasking skills Demonstrated ability to successfully prioritize responsibilities and tasks Effective mentoring skills Effective team building skills Excellent communication and interpersonal skills Ability to meet strict deadlines Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities Skill in use of relevant computer systems and operating environments