Principal Clinical Programmer - EDC Rave

Syneos Health, Inc.; Indiana; Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. is seeking a Principal Clinical Programmer specializing in EDC Rave to lead and support complex clinical programming for single and multi-study programs. The role emphasizes hands-on programming, data capture, processing tools, and collaboration with project teams.

The candidate will oversee development, validation, and documentation, mentor junior staff, and ensure timely delivery while coordinating with clients and vendors across global studies.

Formación

• Targeting 10+ years of experience due to the complexity of integrations and data structure expertise required.
• Strong preference for candidates with hands-on programming experience.
• Provides application administration and technical support as the subject matter expert on core business packages (Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS).
• Designs, writes, validates, and maintains software to meet specifications following standard development procedures.
• Generates and maintains documentation for CRFs, database creation, edit checks, import/export processing, and reports.

Responsabilidades

• Lead development activities for clinical programming projects.
• Attend meetings, provide constructive feedback, and focus on deliverables.
• Mentor and guide other department members in specific skill areas.
• Escalate issues impacting scope, budget, or timelines to project management.
• Oversee QA, validation, and documentation for EDC and processing tools.
• Coordinate system integrations and user acceptance testing.

Conocimientos

Hands-on programming

Herramientas

Medidata

Rave

Oracle OC/RDC

Oracle Inform

SAS

Descripción del empleo

Principal Clinical Programmer - EDC Rave

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• Targeting 10+ years of experience due to the complexity of integrations and data structure expertise required.
• Strong preference for candidates with hands‑on programming experience rather than Data Management profiles.
• Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supplemental packages such as migration mentoring/review, reporting tools, custom functions, etc.
• Utilizes primary development tools and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.
• Monitors applications proactively for workflow alerts, system errors, performance issues and troubleshoot programming deliverable defects.l
• Performs system integrations activities, application updates, and user acceptance testing.
• Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback.
• Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies.
• Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications and uses expanded technical skills to meet evolving project needs.

Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Serves as lead Clinical Programmer to manage and support all functional tasks and project deliverables from single study assignments to large programs of studies. Manages multiple project timelines and deliverable whilst leading less experienced programmers. Designs, writes, validates, and maintains software to meet specifications. Specifies, develops, and validates applications supporting data capture and processing. As senior technical subject matter expert, supports clinical programming and Data Management staff for Electronic Data Capture (EDC), reporting, and processing tools. Proactively monitors internally and externally hosted applications for performance and/or system errors. Supports projects and applications externally. Manages external application vendor issues, integrations, and implementations. May have supervisory responsibility and/or oversight for a team of lead clinical programmers within a program.