Data Manager

Yoh has a long term contract opportunity for a SENIOR DATA MANAGER to join our client, the world leader in the pharmaceutical industry, located in the Summit, NJ.

JOB RESPONSIBILITIES:

- Manage clinical trial databases: Review synopsis and attend Synopsis Review Committee (SRC) meeting
- Review protocols for proper data capture including Case Report Form (CRF) design and CRF completion guidelines Design eCRF specifications according to the protocol
- Lead eCRF development until finalization along with Study Team members
- Lead in the development of a Data Management Plan (DMP), when applicable, that outlines CRF flow, data queries, manual checks, and data listings needed to facilitate data cleaning in accordance to our Comprehensive Data Review Plan (CDRP)
- Develop scripts for UAT as well as perform/coordinate UAT testing
- Work with other DM personnel to create, test and implement data edit checks and data listings
- Ensure coding has been performed and reviewed by Medical Coder
- Trouble-shoot database issues with DBA until resolution is obtained
- Participate in CRO selection and review SOWs/data management activities and costs in contracts
- Work with outside vendors when needed for data entry
- Proficient in writing function SOPs/Working Practices
- Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
- Assist in database upgrades/migrations including performing User Acceptance Tests
- Serve as the DM representative on clinical project teams that are developing NDAs

JOB QUALIFICATIONS:

- BS/BA degree or equivalent in a relevant scientific discipline
- Minimum of five (5) years experience as a lead data manager in a pharmaceutical/CRO setting
- Proficient knowledge of EDC databases, preferably InForm and/or Medidata RAVE.
- Basic knowledge of budget forecasting
- Excellent communication skills
- Ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
- Proficiency in regulatory guidelines, agencies, GCP
- Advanced knowledge of clinical trial process and data management process

PREFERRED JOB SKILLS/EXPERIENCE/KNOWLEDGE:

- Knowledge of Oracle Clinical is a plus.

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Lindsay Lee Morgan

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our Recruitment Process Outsourcing services.

Yoh, a Day J2W: CLINICAL J2WMIDATL

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SFSF: LS