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Clinical Database Programmer (Clinical Data Management Systems Programmers) - NJ in Berkeley Heights, NJ at Apex Life Sciences

Date Posted: 11/20/2018

Job Snapshot

Job Description

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 
  • Develop 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 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 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, Standard and Statistical Programming 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 

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 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 with Rave Module connections a plus 
  • Knowledge of clinical trial design and basic statistics a plus


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.