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  • Posted: Jun 18, 2022
    Deadline: Not specified
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    Syneos Health® is the only fully integrated end-to-end clinical and commercial solution organization. We are purpose-built for biopharmaceutical acceleration, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace. Our business addresses today’s market realities through clinical and commercial sharing exp...
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    Sr Project Data Manager

    Job Responsibilities

    • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
    • Coordinate the work of the assigned Data Management/Data Operations team
    • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
    • Provides project specific training to internal and external audiences as required
    • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
    • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
    • Supports the management of resources on assigned projects/programs
    • Plan, manages and requests resources for assigned projects
    • Develop and maintain project plans, specifications and documentation in line with SOP requirements
    • Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date
    • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
    • Plans for and creates necessary documentation to support internal and external audits; participates in such audits
    • Trains and mentors data management staff, acts as a subject matter expert
    • Prepares input for, and participates in proposal bid defense meetings
    • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences
    • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)

    Qualifications
    What we’re looking for

    • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
    • Clinical data management experience or an equivalent combination of education and experience.
    • Experience in Clinical Data Management practices and relational database management software systems.
    • Strong project management skills and knowledge of project management methodologies
    • Demonstrated staff leadership skills.
    • Contract Research Organization (CRO) experience preferred.
    • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
    • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
    • Effective oral and written communication skills.
    • Strong presentation skills
    • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
    • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
    • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
    • Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management

    Method of Application

    Interested and qualified? Go to Syneos Health Clinical Solutions on www.syneoshealth.com to apply

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