Senior Clinical Programmer, DMSAS

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

📋 Description

• Design, develop, validate, and sustain clinical programming software using Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and associated tools.

• Create and maintain documentation for specifications, programs, validation processes, annotated CRFs, database creation, coding configuration, edit checks, import/export processing, listings, and custom reports.

• Coordinate and lead development efforts for clinical programming projects.

• Engage in project meetings, discussions, problem-solving, and deliverable planning.

• Raise concerns regarding project timelines, scope, or budget issues.

• Provide technological support to clinical programmers, Project Analysts, Data Managers, and related personnel.

• Act as a subject matter expert for primary business and additional clinical programming packages.

• Conduct senior-level reviews of study-level, program-level, and multi-study deliverables.

• Participate in sponsor audits and assist with ongoing audit processes.

• Evaluate study budgets, track scope against actual work, and manage change orders.

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

• Offer second-tier help desk support.

• Execute system integration, application updates, and user acceptance testing.

• Provide leadership, training, guidance, and support to team members within the department.

• Collaborate with clients, peers, lead programmers, project teams, and requestors to finalize specifications.

• Oversee Clinical Programmer activities for designated studies during Quick Start Camps.

• Direct clinical programming tasks across three to ten simultaneous studies.

• Manage project resources and notify management regarding delivery and resource requirements.

• Stay updated with the latest knowledge through literature, self-training, classes, and professional gatherings.

⛳️ Requirements

• Extensive experience and profound expertise in clinical programming and clinical data management.

• Proficiency in Medidata Rave, Oracle OC/RDC, Oracle Inform, SAS, and related tools.

• Capability to design, write, validate, and maintain software in compliance with standard development protocols.

• Experience in developing specifications, programs, and validation documentation.

• Experience in supporting annotated Case Report Forms (CRFs), database creation, coding configuration, edit checks, import/export processing, listings, and custom reports.

• Ability to coordinate and lead activities in clinical programming projects.

• Strong analytical and problem-solving abilities.

• Competence in managing multiple concurrent tasks and studies.

• Experience in providing application administration and technical support.

• Familiarity with system integration, application updates, and user acceptance testing.

• Capable of providing senior reviews for study-level, program-level, and multi-study core deliverables.

• Experience with sponsor audits and ongoing audit processes.

• Background in reviewing study budgets, monitoring scope, and handling change orders.

• Experience in monitoring workflow alerts, system errors, and performance issues.

• Experience in offering second-tier help desk support.

• Skills in leadership, training, guidance, and support.

• Comprehensive knowledge of clinical programming and clinical data management.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Opportunities for professional training and development.