Programmer Analyst I – Clinical Data Managers, Database Designers

Role Overview

• Calling Clinical Data Managers / Database designers with strong experience in protocol interpretaion and edit checks specification keen to be trained in programming!
• Performs programming activities (using Medidata Rave or Veeva) on multiple projects concurrently with less or no support from Senior Programmers.
• Has strong protocol interpretation skills and understanding of Data management documents like Edit check specifications.
• Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE or VEEVA.
• Performs independent programming activities on multiple projects concurrently with less or no support from Senior Programmers.
• Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE or VEEVA.
• Read understand requirement documents/Specifications, database design.
• Reports design and conduct quality control processes including database review to meet client requirements.
• Produce Define XML/pdfs, annotated ECRFs and Reviewers Guide for submission deliverables.
• Develop visual analytics dashboard using tools like Spotfire/Tableau.
• Perform any post-production changes, publish checks, complex structure dynamics, Rave Safety Gateway, Balance (RTSM) mapping setting to the EDC database or enhancements to the programs like edit checks, listings, Protocol Deviations, etc.
• Complete assigned work utilizing EDC tools or other proprietary software according to Fortrea sops, Work Instructions and Instructions, project, and project specific guidelines in accordance with Good Clinical Practices.
• Train and mentor, the team on EDC tools as required and have them ready to perform independent enough on day-to-day activities.
• Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
• Develop/Validate programming specifications for generation of datasets as per Client/CDISC standards.
• Program edit checks/quality checks on source data and communicate data issues to data management.
• Perform quality check and ensure the work is delivered with quality and with knowledge of regulations pertaining to computerized systems to ensure compliance.
• Continuously learn and improve communication, technical and problem-solving skills.
• Interact with project team members in related discipline and provide solutions to the operational issues.
• Able to work independently on multiple sponsors and take initiative to accept new challenges in Clinical Programming Applications.
• Reconcile database build, project files, reports, listings, and other documents related to programming for accuracy, completeness of Data Management processes.
• Work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision of Sr. Programmers.
• Perform other duties as assigned by Manager.

Requirements

• University / college degree (life sciences, health sciences, information technology or related subjects preferred)
• 4
• 7 years of relevant work experience with a minimum of 2 years of experience in protocol interpretation and study build
• Good problem-solving skills and a proactive approach.
• Good oral and written communication skills.
• Good knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred.
• Ability to work in a team environment.
• Ability to work effectively under minimal supervision.
• Ability to prioritize work and Self-motivation.
• Good time management skills and the ability to work to tight deadlines whilst maintain the highest standards of quality work.
• A cooperative and team-oriented approach.

Tech Stack

• Tableau

Benefits

• Home based