Offer summary

Qualifications:

Experience programming custom functions in Medidata RAVE., University/college degree in life science, pharmacy, or related subject preferred., 1+ years of EDC Programming experience in pharmaceutical, biotechnology, or CRO settings., Broad knowledge of drug development processes and effective clinical data management practices..

Key responsibilities:

Program Medidata RAVE custom functions and perform study setup as per specifications.

Participate in the design and maintenance of clinical study databases and ensure adherence to regulatory requirements.

Assist in database release to production and provide technical support to the study team.

Advise management on project status and potential risks, ensuring timely resolution of issues.

Job description

Remote from anywhere in India

Atorus’ industry-leading clinical trial analytics experts build tools and solutions that efficiently facilitate data management and biometrics activities. We carry this out by automating and applying advancing services and technology to maximize trial efficiency, ease interpretation, and prepare your clinical trial data to quickly deliver actionable insights.

Job Overview

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. The EDC Programmer also assists in technical support for data collection systems.

Experience - 1 to 5 Yrs

Job Responsibilities

Programming Medidata RAVE custom functions.
Perform study set up and program edit check programming as per the approved specifications with minimal 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 project-specific 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.

Qualifications And Education Requirements

Experience programming custom functions in Medidata RAVE
University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
1+years EDC Programming experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred
Course completion of an EDC system training
Minimum 1+ 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
Knowledge of effective clinical data management practices

Required profile