Clinical Programmer Lead

CLINICAL PROGRAMMER LEAD
Clinical Data Design, Rave, Inform, Oracle Clinical)

Responsibilities: 

  • Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with internal 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 internal standards 
  • Participate in and lead team meetings when appropriate 
  • Act as primary CRO contact, when necessary, to ensure that internal 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 internal 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 
  • 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 
  • 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 

Qualifications: 

  • BS/BA degree or equivalent in a relevant scientific discipline with 5+ years related Clinical 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 desired
  • 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 clinical trial design and basic statistics a plus
  • Technical project management experience a strong plus
  • Computer skills: knowledge of MS Office program suite