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Clinical Programmer
Ref No.: 18-13197
Location: Berkeley Heights, New Jersey
Position Type:Contract
Start Date / End Date: 09/24/2018 to 12/22/2018
Sunrise System Inc. is currently looking for Clinical Programmer in Berkeley Heights, NJ with one of our top client.
Job Title: Clinical Programmer
Job Id: 18-13197
Location: Berkeley Heights, NJ 07922
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Clinical trial databases
  • Review synopsis and/or protocol and provide Data Manager with comments for the Synopsis Review Committee (SRC) meeting
  • Review protocols for proper data capture including case report form design
  • Assist Data Manager on development of eCRF specifications and review according to the protocol
  • Maintain in-house trials which could include (develop programming, testing and maintaining clinical trial databases) in accordance with Client standards
  • Review computer validation/edit checks if applicable
  • Developing, programming, and testing data review listings in SAS and/or reporting tool for data review purposes if applicable
  • Develop, programming, testing and maintaining computer validation/edit checks in Medidata Rave and/or Oracle Clinical or Inform (Central Designer) if applicable
  • Act as liaison with vendors to establish transfer specifications and Client standards
  • Back-up peer programmer per assignment
  • Project manage multiple complex studies form start up through database lock
  • Participate in and lead team meetings when appropriate
  • Routinely interface with cross-functional team members
  • Provide technical expertise and support to Data Management team
  • Control access to database and perform snapshots, database lock and freeze activities
  • Make data, including interim data, available to company personnel and regulatory agencies when required
  • Mentor junior programmers in more advanced programming skills
    Participate in process improvement initiatives 
Outside CROs
  • Oversee CRO in the design and development of databases that are compatible with company needs
  • Oversee the CRO which involves the design and development of databases, review of appropriate documents e.g. DMP, Edit checks and monitor progress of clinical programming activities
  • Validation of output of CRO to ensure meets specification requirements
  • Liaise with CRO providers, when necessary, to ensure that Client standards are implemented in all studies 
Skills/Knowledge Required
  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years’ experience
  • Advanced knowledge of Clinical Database Design systems is a must. Ability to take full advantage of all of applicable procedures and processes available in Medidata Rave and/or Oracle Clinical or Inform (Central Designer)
  • Participation in at least one NDA is preferred
  • Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
  • Medical or mathematics/computer science background a plus
  • Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation
  • Knowledge of SQL programming 
Computer skills
  • detailed knowledge of Medidata Rave and/or Oracle Clinical or Inform (Central Designer), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite
  • Experience managing clinical programmers a plus
  • Knowledge of clinical trial design and basic statistics a plus. 
Contact
Durga Prasad
Tel:  Direct: 732 272 0279  | Email: durgaprasad.b@sunrisesys.com 
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com