Programmer Analyst I, Clinical Data Managers, Database Designers

This is a fully remote position, open to applicants in India.

📋 Description

• Engages in independent programming tasks across various projects simultaneously with minimal or no assistance from Senior Programmers.

• Develops and implements solutions for global technical service challenges related to EDC tools such as Medidata RAVE or VEEVA.

• Analyzes and comprehends requirement documents/specifications and database design.

• Generates reports, designs, and conducts quality control processes, including database reviews, to satisfy client specifications.

• Creates Define XML/pdfs, annotated ECRFs, and Reviewers Guide for submission deliverables.

• Constructs visual analytics dashboards utilizing tools like Spotfire/Tableau.

• Executes post-production modifications, performs publish checks, manages complex structure dynamics, Rave Safety Gateway, and Balance (RTSM) mapping settings in the EDC database, or enhances programs like edit checks, listings, Protocol Deviations, etc.

• Completes assigned tasks using EDC tools or other proprietary software in accordance with Fortrea's SOPs, Work Instructions, and project-specific guidelines following Good Clinical Practices.

• Trains and mentors the team on EDC tools as necessary, preparing them for independent performance in daily tasks.

• Plans, implements, and supervises all programming activities for a study, including resource estimation, adhering to timelines, ensuring quality, and collaborating with other departments and clients.

• Develops/validates programming specifications for dataset creation according to Client/CDISC standards.

• Programs edit checks and quality checks on source data and communicates data issues to data management.

• Conducts quality checks to ensure deliverables meet quality standards and comply with regulations related to computerized systems.

• Continuously enhances communication, technical, and problem-solving skills.

• Collaborates with project team members in related disciplines to provide solutions for operational challenges.

• Capable of working independently across multiple sponsors and proactively embracing new challenges in Clinical Programming Applications.

• Reconciles database builds, project files, reports, listings, and other programming-related documents for accuracy and completeness concerning Data Management processes.

• Operates in a timely manner, adhering to all specified activities within the agreed study budget, under the guidance of Senior Programmers.

• Undertakes additional responsibilities as assigned by the Manager.

⛳️ Requirements

• A university or college degree in life sciences, health sciences, information technology, or related fields is preferred.

• Relevant work experience or education equivalent to a bachelor's degree may be accepted in place of a formal degree.

• 4 to 7 years of pertinent work experience with at least 2 years focusing on protocol interpretation and study build.

• Strong problem-solving abilities and a proactive mindset.

• Excellent verbal and written communication skills.

• Familiarity with the clinical trial process and data management, biometrics, and systems applications to support operations is advantageous.

• Ability to thrive in a team-oriented environment.

• Effective under minimal supervision.

• Capacity to prioritize tasks and self-motivate.

• Proficient in time management and capable of meeting tight deadlines while maintaining high-quality standards.

• A collaborative and team-focused attitude.

🏝️ Benefits

• Home based