Data Manager, Sr. - NJ
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Data Manager, Sr. - NJ
Ref No.: 16-00913
Location: Berkeley Heights, New Jersey
Start Date / End Date: 05/02/2016 to 05/07/2017
Responsibilities will include, but are not limited to:

1. Manage clinical trial databases:

Review synopsis and attend Synopsis Review Committee (SRC) meetingReview protocols for proper data capture including Case Report Form (CRF) design and CRF completion guidelines Design eCRF specifications according to the protocol
Develop eCRF guidelines according to design of the eCRF
Lead eCRF development until finalization along with Study Team members
Assigned to more complex studies
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 and test edit specifications
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
Generate data query forms to be resolved at investigational sites, when applicable
Ensure coding has been performed and reviewed by Medical Coder
Perform external data reconciliation
Provide specific data listings as required by the medical group and review when necessary
Make data, including interim data, available to company personnel and to regulatory agencies when required
Trouble-shoot database issues with DBA until resolution is obtained
Perform database lock and freeze activities
Prepare/present at Investigator Meetings

2. Manage outside CROs and consultants:

Participate in CRO selection Review SOWs/data management activities and costs in contracts
Work with outside vendors when needed for data entry
Assess CRO data management systems for regulatory compliance
Interact with CROs in the design and development of databases that are compatible with company needs
Monitor progress of data management activities in CROs
Participate in regular team meetings and provide input when sppropriate

3. Other Activities:

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
Train Data Managers on Client standards and processes
Serve as the DM representative on clinical project teams that are developing NDAs

Skills/Knowledge Required:

BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience as a lead data manager in a pharmaceutical/CRO setting
Proficient knowledge of EDC databases, preferably InForm and/or Medidata RAVE. Knowledge of Oracle Clinical is a plus.
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