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Clinical Programmer - NJ
Ref No.: 16-00910
Location: Berkeley Heights, New Jersey
Start Date / End Date: 04/07/2016 to 04/29/2017
Title: Clinical Programmer - NJ
Location: Berkeley Heights, NJ
Duration: Immediately-04/29/2017
Job#: CELGJP00003999

Responsibilities will include, but are not limited to:

1. 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 Oracle Clinical and/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 startup 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
2. 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 Oracle Clinical and/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 Oracle Clinical and/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