Senior Clinical Programmer, Rave

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

📋 Description

• Serve as a 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 maintain software in accordance with specifications and established development protocols.

• Generate and sustain documentation for annotated CRFs, database creation, coding configurations, edit checks, imports, exports, listings, and tailored reports.

• Monitor applications for workflow notifications, system errors, performance challenges, and programming defects.

• Execute system integrations, application upgrades, and user acceptance testing.

• Lead development efforts for clinical programming projects while communicating risks that may impact timelines, scope, or budget.

• Engage in project, departmental, and bid defense meetings.

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

• Attend sponsor audits and assist during ongoing audits.

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

• Mentor, train, guide, and support team members within the department.

• Participate as the lead Clinical Programmer in Quick Start Camps.

• Offer leadership and oversight for five to twenty concurrent studies.

• Manage project resources and vendor relationships, including service level agreements (SLAs).

• Supervise upgrades and new module implementations for remotely hosted vendors.

• Revise standard operating procedures and work instructions.

• Oversee clinical programming operations and staff development as necessary.

⛳️ Requirements

• Proficiency in Rave Programming.

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

• At least 2+ years of experience in Custom Functions (CF).

• Overall experience of 5–7+ years in the field.

• Exposure to migration processes.

• Familiarity with Publish Check, PPC, and TSDV.

• Experience in Study Build programming.

• SDBE Rave certification is mandatory.

• Veeva CDMS experience is preferred.

• Comprehensive understanding of clinical programming and clinical data management.

• Ability to design, write, validate, and maintain software effectively.

• Capability to create and maintain necessary technical and validation documentation.

• Proficient in performing system integrations, application updates, and user acceptance testing.

• Skilled in leading clinical programming project activities and supervising concurrent studies.

• Competent in managing project resources, metrics, budgets, scope, and change orders.

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

• Proficient in managing application vendors and monitoring service level agreements (SLAs).

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Access to technical and therapeutic area training.

• Peer recognition programs.

• Comprehensive total rewards program.

• Inclusive workplace culture.

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