Principal Clinical Programmer, Rave Programming

🔥 11 hours ago

🇮🇳 India – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide application administration and technical support as the subject matter expert for Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, migration tools, reporting tools, and custom functions • Design, write, validate, and maintain clinical programming software • Develop specifications, coding, validation documentation, CRF support, database creation, coding setup, edit checks, imports, exports, listings, and custom reports • Monitor applications for workflow alerts, system errors, performance issues, and programming defects • Perform system integrations, application updates, and user acceptance testing • Coordinate and lead development activities for clinical programming projects • Communicate project issues affecting timelines, scope, or budget and escalate problems • Participate in project and departmental reviews, bid defenses, sponsor audits, and in-progress audits • Provide senior review of program-level and multi-study core deliverables • Review study budgets and manage program metrics, progress, status, scope, and change orders • Lead, mentor, train, and support department members • Attend Quick Start Camps as lead Clinical Programmer • Provide oversight for five to twenty concurrent studies, including other lead programmers and associated studies • Manage project resources and application vendors, including SLAs and vendor metrics • Supervise implementation of upgrades and new modules for remotely hosted vendors • Update standard operating procedures and work instructions • Oversee clinical programming operations and supervise clinical programmers as required

🎯 Requirements

• Experience in Rave Programming • Custom Functions Programming (Moderate to Complex) • Minimum 2+ years in Custom Functions Programming • Overall 10+ years of experience • Migration exposure • Publish Check, PPC, TSDV, and Study Build programming experience • SDBE Rave certification mandatory • Preferred Veeva CDMS experience • Broad knowledge of clinical programming and clinical data management • Ability to design, write, validate, and maintain software following standard development procedures • Ability to generate and maintain technical and validation documentation • Ability to perform system integrations, application updates, and user acceptance testing • Ability to lead clinical programming project activities and oversee multiple concurrent studies • Ability to manage project resources, vendors, service-level agreements, budgets, metrics, and change orders • Ability to provide leadership, mentorship, training, guidance, and supervision • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Professional development, training classes, and professional meetings