Principal Clinical Programmer

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

📋 Description

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

• Create and uphold documentation for specifications, programming, validation, annotated CRFs, databases, coding, edit checks, imports, exports, listings, and bespoke reports.

• Coordinate and oversee development efforts for clinical programming initiatives.

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

• Raise concerns regarding project timelines, scope, or budget as necessary.

• Offer technological support to clinical programmers, Project Analysts, Data Managers, and other personnel.

• Administer and provide technical assistance for core business applications and supplementary packages.

• Conduct senior reviews of deliverables at the study, program, and multi-study levels.

• Attend sponsor audits and assist with ongoing audit processes.

• Assess study budgets, track scope against actual activities, and manage change orders.

• Monitor workflow alerts, system errors, and performance challenges.

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

• Offer leadership, training, guidance, and support to team members.

• Collaborate with clients, colleagues, lead programmers, project teams, and requesters to finalize specifications.

• Serve as the lead Clinical Programmer for assigned studies at Quick Start Camps.

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

• Manage project resources and proactively communicate delivery and resourcing requirements.

• Stay up-to-date with current knowledge through literature, self-education, courses, and professional gatherings.

⛳️ Requirements

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

• Proficient with Medidata Rave, Oracle OC/RDC, Oracle Inform, SAS, and related supporting tools.

• Capability to design, develop, validate, and maintain software according to specifications and standard development protocols.

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

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

• Strong analytical and problem-solving abilities.

• Capacity to manage multiple concurrent tasks and studies effectively.

• Ability to provide technological support and second-tier help desk assistance.

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

• Capability to conduct senior reviews of core deliverables at the study, program, and multi-study levels.

• Ability to evaluate study budgets, monitor the scope of work, and manage change orders.

• Ability to provide leadership, training, guidance, and support to department staff.

• Comprehensive knowledge of clinical programming and clinical data management.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations, when appropriate, for employees or applicants with disabilities.