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:
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.
Our company offers very competitive compensation and benefit plans, including: