Scientist, Clinical Data Manager

Employer
Reynolds
Location
Winston-Salem, North Carolina
Posted
Apr 20, 2021
Closes
May 05, 2021
Ref
74301dc59570
Organization Type
Corporate
Job Number: [[id]]

Reynolds American Incorporated is positively transforming the tobacco industry. We're 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 Reynolds American, we focus on the growth of our people. We take pride in each other's 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.

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; Modoral Brands, Inc.; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; Reynolds Brands, Inc.; and Vuse Stores LLC. This position is with [[custContractualLE]].

Here, you'll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.

The Lead Clinical Data Manager is responsible for the oversight of all data management tasks from study start-up to database lock to produce a clean and analyzable database. The lead data manager oversees contractors who independently lead and/or efficiently perform all data management activities within an assigned study and communicates with management regarding the status of data management activities within all studies. The individual must be able to manage and/or execute multiple projects simultaneously. The incumbent will actively partner across functional areas within RJRT and with external vendors to ensure R&D project deliverables and timelines are met. Additionally, the candidate will be responsible for the oversight of global DM processes such as data standards development and SDTM review processes, including the management of external vendors who may provide these services.

Principal Duties & Responsibilities include:


  • Design - Design and deliver eCRF specifications according to protocol and approved standards; oversee development of new standards.

  • Manage - Manage and monitor data management activities with CRO's or other vendors. Assist in development of request for proposal (RFP) for data management needs. Manage external DM contractors.

  • Lead - Oversee DM contractors as point of contact between vendor and RAIS for all data management activities. Provide support for DM contractors to include: all data management activities with vendor (eCRF screens, edit check specifications, data management plan, SAE reconciliation, coding, database lock, etc.). Ensure internal study team is updated on these activities. Drive the internal user acceptance testing process. Provide thought leadership on DM strategies, including EDC platforms and outsourcing.

  • Collaborate - Collaborate with appropriate project teams as needed to stay abreast of changes that could affect data collection, cleaning and/or data transfers. Participate in regular team meetings and provide updates as needed.



Required Knowledge and Experience:


  • Bachelor's degree required.

  • 5+ years of work experience in clinical data management with a fundamental knowledge of the data management processes.

  • Minimum of 3 years' experience in vendor management.

  • Proficiency using multiple Electronic Data Capture Systems, such as: Oracle Clinical, Medrio, Inform, Medidata Rave, etc.



Strongly Preferred:


  • Experience with FDA regulatory submissions. CTP submissions familiarity would be a plus.

  • Basic programming (SQL/SAS preferred) knowledge.

  • Knowledge of CDISC/CDASH and the implementation of SDTM standards.

  • Knowledge of biology, chemistry, toxicology, pharmacy, public health or related discipline





The Ideal Candidate will possess:


  • Ability to drive collaborative efforts cross-functionally and externally with outsourced vendors.

  • Ability to work and make decisions with minimal supervision.

  • Excellent project management, time management and team collaboration skills.

  • Effective oral and written communication skills.

  • 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 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



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 via email at TalentAcquisition@RJRT.com.

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