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Senior Data Manager
Ref No.: 18-15246
Location: Berkeley Heights, New Jersey
Position Type:Contract
Start Date / End Date: 10/29/2018 to 10/26/2019
Sunrise System Inc. is currently looking for Senior Data Manager in Berkeley Heights, NJ with one of our top client.
Job Title: Senior Data Manager
Job Id: 18-15246
Location: Berkeley Heights, NJ 07922
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Responsibilities will include, but are not limited to
  • 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. 
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
  • Must have relevant and extended experience.
  • Must be able to work with minimal supervision.
  • Must be able to communicate well.
  • Must have experience in managing data management deliverables end to end. Project driven, not task driven.
  • 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 Medical Affairs
  • Experience in Haematology 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. 
Contact
Sunny Rajput
Direct: (732) 272 0302 | Email: Sunny.R@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com