Lead Clinical Data Manager

Location: Basking Ridge, New Jersey Salary: competitive
Sector: Pharma & Biotech Type: Contract

Responsibilities will include, but are not limited to:

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
  • 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

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 appropriate

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 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

Sthree US is acting as an Employment Business in relation to this vacancy.