Sr Data Manager #7477

Location: Berkeley Heights, New Jersey Salary: medical,dental,vision,401k
Sector: Pharma & Biotech Type: Contract

Job Title: Sr Data Manager

Location: Berkeley Heights, NJ

Duration: one year from start date

Hours: 830am-5pm 40 Hrs/Wk (some flexibility in start/end times)

Compensation: DOE

100% onsite initially ... (1-day work from home will be considered after first 3 months.)

Responsibilities will include, but are not limited to:

  1. Manage outside CROs and consultants:
  • Participate in CRO selection
  • Review SOWs/data management activities and costs in contracts
  • Interact with CROs in the design and development of CRF's, databases that are compatible with Standards, CDISC and all other company needs
  • Perform QC of CRO activities to include UAT, Query management, Data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
  • Monitor progress of data management activities by CROs
  • Participate in regular team meetings and provide input when appropriate
  • Ensure inspection readiness by ensuring quality eTMF.

  1. 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 QC of CRO User Acceptance Tests

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
  • Knowledge of RECIST 1.1
  • Experience in Hematology and or Oncology
  • Proficient knowledge of EDC databases, preferably 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
  • Advanced knowledge of Microsoft Office
  • DM lead experience in all phases of a trial (study start-up, conduct, and close-out)

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