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Clinical Programmer – NJ

Berkeley Heights, New Jersey Apex Life Sciences

Responsibilities will include, but are not limited to:

– 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 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 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 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

Job ID: ******

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Apex Life Sciences

On Assignment’s U.S. life sciences businesses, Lab Support and Valesta Clinical Research Solutions, have been re-branded as Apex Life Sciences. The U.S. divisions of Lab Support and Valesta are leaders in the scientific, engineering, and clinical research staffing and services industry. The new name was chosen to leverage the national brand of On Assignment’s Apex Systems, a leader in the technology staffing and services industry. For over 30 years, Lab Support and Valesta have provided top talent for contract, contract-to-hire, and direct hire positions in the life sciences industries. With hundreds of thousands of successful matches over three decades, the divisions have built reputations as the best in the business. Contact Info

– Berkeley Heights, NJ

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