Clinical Programmer II

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

📋 Description

• Employ Oracle RDC, Oracle Inform, Medidata, Rave, SAS, and associated tools to create, write, validate, and sustain software.

• Develop and uphold documentation for specifications, coding, validation, CRFs, database creation, coding configuration, edit checks, imports, exports, listings, and custom reports.

• Participate in project teams and coordinate or lead clinical programming development efforts.

• Attend meetings, engage in discussions, analyze problems, and concentrate on deliverables.

• Report issues impacting project timelines, scope, or budget and escalate potential challenges.

• Manage multiple assignments and communicate resource requirements to supervisors.

• Evaluate study-level core deliverables for precision and assist with sponsor and ongoing audits.

• Review study budgets and track the scope of work against actual performance.

• Offer leadership, training, guidance, and support to members of the department.

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

• Support project review and departmental review meetings.

• Participate in Quick Start Camps as the lead clinical programmer for designated studies.

• Oversee clinical programming activities for as many as eight concurrent studies.

• Manage project resources and notify management of delivery and resourcing requirements.

• Keep clinical programming and clinical data management knowledge current through literature, self-training, classes, and professional meetings.

⛳️ Requirements

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

• Proficient in Oracle RDC, Oracle Inform, Medidata, Rave, SAS, and other related tools.

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

• Skill in developing specifications, coding, and validation documentation for annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import/export processing, listings, and custom reports.

• Ability to coordinate and oversee development activities for clinical programming projects.

• Analytical approach to problem-solving.

• Capability to manage multiple assignments and up to eight concurrent studies.

• Competence in reviewing study-level core deliverables for accuracy.

• Ability to engage in sponsor and ongoing audits.

• Skill in reviewing study budgets and monitoring the scope of work against actual performance.

• Capacity to provide leadership, training, guidance, and support to department members.

• Ability to collaborate effectively with clients, colleagues, lead programmers, project teams, and requestors.

• Comprehensive knowledge of clinical programming and clinical data management.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

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