Principal Clinical programmer DMSAS
Syneos Health1 day ago
Remote, India or Hyderābād, IndiaStaff+
Responsibilities
- Design, write, validate, and maintain clinical programming software using Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supporting tools.
- Develop and maintain specifications, programs, validation documentation, databases, coding configurations, edit checks, import/export processes, listings, and custom reports.
- Lead clinical programming activities for three to ten concurrent studies and coordinate project deliverables, resources, scope, budgets, and timelines.
- Provide application administration, technical support, system integration, application updates, user acceptance testing, workflow monitoring, and second-tier help desk support.
- Perform senior reviews of study-level, program-level, and multi-study core deliverables to ensure accuracy and quality.
- Support sponsor and in-progress audits and provide input and supporting details for change orders.
- Provide technology leadership, training, guidance, and support to clinical programming staff, project analysts, data managers, and other department members.
- Collaborate with clients, peers, lead programmers, project teams, and requestors to clarify and finalize specifications.
- Serve as the lead Clinical Programmer for assigned studies during Quick Start Camps and participate in project and departmental review meetings.
- Maintain broad knowledge of clinical programming and clinical data management through literature review, self-training, courses, and professional meetings.
Requirements
- Broad overall knowledge and expertise in clinical programming and clinical data management.
- Expertise with clinical programming development, validation, documentation, database creation, coding configuration, edit checks, data imports and exports, listings, and custom reports.
- Experience providing technical leadership, senior reviews, application administration, project coordination, and support across multiple concurrent studies.
- Ability to collaborate with clients and cross-functional project teams, manage competing assignments, communicate resource needs, and escalate project risks.
- Ability to provide training, guidance, and subject-matter expertise to clinical programming and clinical data management staff.
- Equivalent experience, skills, and/or education will also be considered.
Benefits
- Career development and progression opportunities.
- Supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.
- Inclusive culture and opportunities to collaborate with colleagues globally.
- The role may include participation in sponsor audits, professional meetings, training classes, and Quick Start Camps.
Tech Stack
Sass
Categories
About Syneos Health
Syneos Health provides outsourced clinical development and commercialization services to pharmaceutical and biotech companies, spanning clinical trials, medical affairs, and product launch support. The company operates under fee-for-service and functional service provider models across global drug development. Headquartered in Morrisville, NC, it was formed in 2017 through the merger of INC Research and inVentiv Health and was acquired in 2023 by affiliates of Elliott Management.