Syneos Health · 3 weeks ago
Principal Clinical programmer (Veeva/Rave)
United States
Full-time
Remote
Lead/Staff
8+ years expSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Principal Clinical Programmer will provide application administration and technical support, ensuring high-quality deliverables while leading clinical programming projects and mentoring team members.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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
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
Participates in and provides input at project review and departmental review meetings. Participates in bid defenses
Ensures high quality deliverables by providing senior review of ’program level’/multi-study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits
Reviews and provides input on study budgets, manages project level metrics, progress, and status, for large programs of studies from key sponsors. Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Assists with the creation of change orders
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
Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies
Provides leadership/oversight of five (5) to twenty (20) concurrent studies depending upon scope, similarity, program, and resourcing requirements. This may include the oversight of other lead programmers and their associated studies
Manages project resources, proactively alerting management of delivery and resourcing needs
Assists with management of application vendors and serves as an initial escalation contact. Monitors vendor service level agreements (SLAs) and reports metrics to upper management
Supervises the implementations of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas
Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc
Contributes towards the update of standard operating procedures and work instructions in line with department and company process and policy
As required, oversees program level clinical programming operations by providing supervision for a team of clinical programmers. Responsibilities may include professional development performance appraisals, and employee advising for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff development by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level. Resolves conflicts/priorities at the program level prior to making any recommendations to management. Advises on administrative policies and procedures, technical problems, priorities, and methods
Qualification
Required
Bachelor's degree, in lieu of Bachelor's degree, equivalent related education and experience
8 - 9 years of experience in clinical programming
End to End Clinical Programming experience in Rave OR Veeva, with hands-on with EDC build
Study/DB Build, eCRF Build, Edit Checks programming, Migrations & PPC experience
Strong Custom Functions programming experience if its Rave EDC; SAS is not required though
The ability to deal effectively with sponsors and internal customers at all levels
Excellent communication and interpersonal skills, both written and spoken, with an ability to inform
Demonstrated experience in managing multiple priorities in a highly dynamic environment
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail
Ability to travel as necessary (up to 25%)
Preferred
Master's degree preferred
Experience working in a matrix-structured environment
Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Michael Bonello
Executive Vice President and Chief Financial Officer
Michael Brooks
Chief Operating Officer
Recent News
2026-01-09
2025-12-01
Company data provided by crunchbase