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Clinical Data Manager

Company: RAI Services Company
Location: Winston Salem
Posted on: October 8, 2018

Job Description:

Reynolds American Incorporated is positively transforming the tobacco industry. Were a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are redefining the ways adult tobacco consumers enjoy tobacco in the 21st century.

When other companies talk about growth, they only talk about size. At RAI, we focus on the growth of our people. We take pride in each others growth and well-being throughout our careers. We invest in your career and total well-being because we know our companies succeed when our people thrive.

At the RAI companies youll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.

This position is within Reynolds American Services Companya subsidiary that provides support services, including compliance, HR, law, finance, informationmanagement, and more to all of the subsidiaries ofRAI.

RAI Services Company (RAIS) is seeking a creative, resourceful Clinical Data Manager to lead clinical data management activities for clinical studies with new and existing tobacco products to support regulatory submissions and to further advance the science of tobacco harm reduction.
The incumbent will be responsible for all Data Management tasks from study start-up to database lock and close-out to produce a clean and analyzable database. The Clinical Data Manager will independently perform all data management activities and/or oversee and coordinate tasks delegated to the data management team of a CRO. The individual will also manage and oversee the activities of contract data management staff.

The Clinical Data Manager will actively partner with other functional areas within RAI (e.g., Biostatistics, Project Management) and with external vendors to ensure data management aspects of the project are appropriately considered and deliverables and timelines are met. The individual will be the key point of contact between the vendors and RAIS on all data management activities. The person must be able to manage and/or execute multiple studies.

Principal Duties and Responsibilities:

  • Lead all data management activities with CROs from study start-up through database lock, including database design.
  • Design case report forms and eCRF specifications according to protocol and approved standards; assist in development of new standards.
  • Develop and/or review relevant data management documents, such as CRF Completion Guidelines, Data Management Plans, Data Validation Plans, and Data Transfer Plans.
  • Perform and/or oversee database validation including development of data validation and edit check specifications, generation of test scripts, and driving the User Acceptance Testing (UAT) process.
  • Review or perform reconciliation activities (external data, serious adverse events (SAEs), Central Labs, IVRS)
  • Oversee or participate in database lock activities, including authoring or reviewing lock documentation.
  • Assist in the development of Request for Proposal (RFP) documents for data management needs.
  • Work collaboratively with project study teams comprised of internal staff and external vendors.POSITION QUALIFICATIONS
    Required Knowledge and Experience:
    • Bachelors degree required
    • A minimum of 5 years of clinical data management experience including 3 years of experience as a data management lead
    • Experience in vendor management
    • Experience and proficiency in multiple clinical data management systems (e.g., Inform, Medrio, Rave, Oracle Clinical) Strongly Preferred:
      • Experience in Project management (within Clinical Data Management)
      • Experience with FDA regulatory submissions.
      • Knowledge of CDISC/CDASH and the implementation of SDTM standards.
      • Basic programming (SQL/SAS preferred) knowledge.
      • Knowledge of clinical research industry, biology, chemistry, toxicology, pharmacy, public health or related discipline
      • Knowledge of time and cost estimate development, and pricing strategies for data management. The Ideal Candidate will possess:
        • Ability to drive collaborative efforts cross-functionally and externally with outsourced vendors and contractors.
        • Ability to work and make decisions with minimal supervision.
        • Excellent project management, time management and team collaboration skills.
        • Ability to lead more than one project and prioritize accordingly.
        • Excellent communication skills, both oral and written.
        • Interpersonal skills of dependability, reliability, and credibility.Compensation/Targeted Bonus
          • Competitive Annual Salary
          • Targeted Annual Bonus
          • Relocation assistance available for those who qualify.Benefit Summary
            Our company offers very competitive compensation and benefit plans, including:
            • 401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation. Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
            • Comprehensive health- and welfare-benefits package
            • Eleven paid company holidays annually, plus a generous paid vacation plan based on length of service
            • Company-paid sick and personal days, funeral leave and jury duty leave
            • Confidential personal financial counseling service
            • On-site health clinics and fitness centers
            • A matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
            • Health-care advocacy service
            • Volunteer service opportunities
            • Federal credit union membership through Allegacy Federal Credit Union
            • Extensive training opportunities ABOUT OUR ORGANIZATION:
              Reynolds American Inc. is an indirect, wholly owned subsidiary of British American Tobacco p.l.c., and the U.S. parent company of R. J. Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; Niconovum USA, Inc.; Niconovum AB;R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; and Reynolds Brands, Inc..

              Reynolds American Inc. and its affiliated companies is an Equal Opportunity / Affirmative Action Employer.

              All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

              Our organization offers a level of challenge, responsibility and creativity for motivated employees that stands apart from the crowd.

              We are also committed to employing a diverse workforce and valuing different perspectives, experiences and talents to maximize the company's potential for successfully achieving its business objectives.
              -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

              Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.
              Telephone: 262-###-####
              Email:

              Associated topics: data administrator, data analytic, data integration, data integrity, data manager, data quality, data warehouse, data warehousing, mongo database administrator, teradata

              Keywords: RAI Services Company, Winston-Salem , Clinical Data Manager, Executive , Winston Salem, North Carolina

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