Edc Programmer - India - Atorus Research Inc.

Description

The Electronic Data Capture (EDC) Programmer is responsible for providing support in creating, deploying and maintaining clinical databases and provides EDC programming support to the study team in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements.

• Programming Medidata RAVE custom functions
• Perform study set up and program edit check programming as per the approved specifications with mínimal guidance from the line manager or experienced colleagues
• Adhere to project timelines
• Participate in the design and maintenance of the clinical study database per the protocol and any amendments, SOPs, GCP and other regulatory requirements
• Review database specifications and Data Validation Specifications (DVS) and perform programming and configuration activities
• Assist in database release to production activities
• Provide programming or other support and assist CDM managers in daily technical operations. Respond to and solve technical oriented problems in a timely manner, as appropriate for the position. Assist data manager with status reports and listings as necessary
• Advise management on a regular basis on the status and any potential risks or concerns with ongoing projects to ensure timely resolution including any potential issues with resources
• Ensure awareness of projectspecific quality and performance standards and ensure that these are adequately documented, communicated, and understood
• Participate in internal and external study team meetings, as required
• Participate in department meetings and initiatives
• Perform other duties as required by the department

• Experience programming custom functions in Medidata RAVE
• 24years EDC Programming experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred
• Course completion of an EDC system training
• Minimum 24 years of experience in clinical database design and deployment
• Additional relevant work experience will be considered in lieu of formal qualifications
• Broad knowledge of drug development processes
• Understanding of global clinical development budgets and relationship to productivity targets