Principal Clinical Programmer, Rave Programming

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

📋 Description

• Serve as the subject matter expert by providing application administration and technical support for Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, migration tools, reporting tools, and custom functions.

• Design, develop, validate, and sustain clinical programming software.

• Create specifications, coding, validation documentation, CRF support, database setups, coding configurations, edit checks, imports, exports, listings, and custom reports.

• Monitor applications for workflow alerts, system errors, performance issues, and programming defects.

• Conduct system integrations, application updates, and user acceptance testing.

• Coordinate and lead development initiatives for clinical programming projects.

• Communicate any project issues that impact timelines, scope, or budget, and escalate problems as necessary.

• Participate in project and departmental reviews, bid defenses, sponsor audits, and ongoing audits.

• Provide senior-level review of program-level and multi-study core deliverables.

• Review study budgets and oversee program metrics, progress, status, scope, and change orders.

• Lead, mentor, train, and support team members within the department.

• Attend Quick Start Camps as the lead Clinical Programmer.

• Oversee five to twenty concurrent studies, including other lead programmers and associated studies.

• Manage project resources and application vendors, including SLAs and vendor metrics.

• Supervise the implementation of upgrades and new modules for remotely hosted vendors.

• Update standard operating procedures and work instructions.

• Oversee clinical programming operations and supervise clinical programmers as needed.

⛳️ Requirements

• Proficient in Rave Programming.

• Experience in Custom Functions Programming (Moderate to Complex).

• At least 2+ years of experience in Custom Functions Programming.

• A minimum of 10+ years of overall experience.

• Exposure to migration processes.

• Experience with Publish Check, PPC, TSDV, and Study Build programming.

• SDBE Rave certification is mandatory.

• Preferred experience with Veeva CDMS.

• Broad understanding of clinical programming and clinical data management.

• Capability to design, write, validate, and maintain software in accordance with standard development procedures.

• Skill in generating and maintaining technical and validation documentation.

• Ability to perform system integrations, application updates, and user acceptance testing.

• Competence to lead clinical programming project activities and oversee multiple concurrent studies.

• Proficient in managing project resources, vendors, service-level agreements, budgets, metrics, and change orders.

• Ability to provide leadership, mentorship, training, guidance, and supervision.

• Equivalent experience, skills, and/or education may be considered.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Total rewards program.

• An inclusive culture.

• Professional development, training classes, and participation in professional meetings.