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Clinical Programmer (Rave, edit checks, onsite NJ) (Science & Biotech)
Summit, NJ 07901
Recruited by: Ali Henderson | Senior Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: SimulStat's client
  • Industry: Science & Biotech
  • Compensation: Depends On Experience
  • Expires: Dec 02, 2019
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Job Description

1 year renewable contract
- Onsite NJ
Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with standards
Lead collaborative cross-functional team study build meetings for in-house and outsourced studies
Review edit checks for in-house and outsourced studies
Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and standards
Participate in and lead team meetings when appropriate
Act as primary CRO contact, when necessary, to ensure that standards are implemented in all studies
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
Perform post processing of data extracts in accordance with standards to be delivered to Biostatistics
Routinely interface with cross-functional team members
- Influences other functions and represents as DBO technical expertise
- Internal team leader who decides best course of action
- Coach and advise junior programmers to identify problems and solutions

1. Manage outside CROs and consultants:
Review clinical programming activities and costs in contracts
Assess CRO data management systems for regulatory compliance
Interact with CROs in the design and development of databases that are compatible with company needs
Monitor progress of clinical programming activities in CROs
Participate in regular team meetings and provide input when appropriate

2. Other Activities
Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock.
Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities
Direct responsibility for supervising and training junior clinical programmers in the performance of their duties
Managing project priorities and timelines

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 is a must (Rave, Inform, Oracle Clinical or other systems). Safety Gateway, TSDV, Site Payments and Coder experience a plus
Good communication skills; ability to work in a team environment with data managers, 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
Computer skills: knowledge of MS Office program suite
Knowledge of clinical trial design and basic statistics (a plus)