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Clinical Data Manager / Principal Clinical Data Manager (Home-based)

Company: IQVIA
Location: Durham
Posted on: September 9, 2020

Job Description:

Job Description: IQVIA--- is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Overview: IQVIA is seeking high performing Clinical Data Managers and Principal Clinical Data Managers. Principal Data Managers oversee data operations tasks for a team of data managers from study start-up to database lock, to produce a clean and analyzable database. These roles can be full time home-based or matched to office-based roles depending on client alignment. Responsibilities: * Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies * Provide leadership to CDM team. * Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues. * Provide marketing capabilities presentations and business development presentations. Or serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task. * Serve as back-up for Data Operations Coordinator or Data Team Lead * Provide leadership to Operations team * Provide technical expertise. Or serve as a Subject Matter Expert (SME) * Provide leadership and expertise in a specific CDM task or technology. Manage delivery of projects through full data management process life-cycle. * Management of:Project timelines, Quality issues, Resource management * SOW (scope of work) / budget. Provide justification for customer negotiations. May serve as Project Manager for single service data management projects. Manage comprehensive data management tasks pertaining to the documented project specifications. Manage comprehensive quality control procedures. Provide data management expertise and data management process improvement to CDM management. Mentor other team members in training and developing data management expertise. Independently bring project solutions to the CDM team and the CDM Department. Manage a focus team or a best practice team. Manage the development and implementation of new technology/tool. Present at professional conferences and/or publish articles in professional journals. Provide CDM with technical expertise. Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions. Perform other duties as directed by the functional manager. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM and project teams. Skills & Abilities: * Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology. * Knowledge of operating procedures and work instructions and the ability to apply them in practice. * Excellent experience and organizational, communication, and demonstrated expert data management skills. * Comprehensive understanding of clinical drug development process (detail oriented). * Ability to establish and maintain effective working relationships with coworkers, managers and clients. * Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology. * Knowledge of operating procedures and work instructions and the ability to apply them in practice. * Excellent experience and organizational, communication, and demonstrated expert data management skills. * Comprehensive understanding of clinical drug development process (detail oriented). * Ability to establish and maintain effective working relationships with coworkers, managers and clients. Minimum Required Education & Experience: Experience: * 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials > 1000 patients, and including experience handling customer negotiations (e.g. bid defense meetings). Education: * Bachelor's Degree in clinical, biological or mathematical sciences, or related field or nursing qualification Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater pu

Keywords: IQVIA, Durham , Clinical Data Manager / Principal Clinical Data Manager (Home-based), Executive , Durham, North Carolina

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