Reynolds American Inc. (RAI) Clinical Data Manager in Winston-Salem, North Carolina
Clinical Data Manager
Date:Jul 28, 2017
Location:Winston-Salem, NC, US
Reynolds American Incorporated (NYSE: RAI) 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 RAI, 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.
At the RAI companies you’ll 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 Company—a subsidiary that provides support services, including compliance, HR, law, finance, information management, and more to all of the subsidiaries of RAI.
The Clinical Data Manager is responsible for all data management tasks from study start-up to database lock to produce a clean and analyzable database. The data manager independently leads and/or efficiently performs all data management activities within an assigned study and communicates with management regarding the status of data management activities within their studies. The individual must be able to manage and/or execute multiple projects simultaneously. The incumbent will actively partner across functional areas within RAI and with external vendors to ensure project deliverables and timelines are met.
Principal Duties & Responsibilities include:
Design – Design eCRF specifications according to protocol and approved standards; assist in 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.
Lead – Lead all data management activities with vendor (eCRF screen development, edit check specifications, data management plan, SAE reconciliation, coding, database lock, etc.). Point of contact between vendor and RAIS for all data management activities. Ensure internal study team is updated on these activities. Drive the internal user acceptance testing process.
Collaborate - Collaborate with 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, Medadata Rave, etc.
Experience with FDA regulatory submissions.
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.
Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
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. (NYSE: RAI) is the parent company of R.J. Reynolds Tobacco Company; American Snuff Company, LLC; Santa Fe Natural Tobacco Company, Inc.; Niconovum USA, Inc.; Niconovum AB; and R.J. Reynolds Vapor Company.
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.
Onlyapplicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.
Nearest Major Market:Winston-Salem