Senior Principal Clinical Programmer

September 27

Apply Now

Receive Emails with Similar Jobs

Syneos Health

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Provides clinical programming technical support and expertise across the DM/Clinical Programming function and other departments as needed. • Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Veeva, SAS, Python, Spotfire, 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 troubleshoots programming deliverable defects. • Performs system integration 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. • Participates in and provides input at project review and departmental review meetings; participates in bid defenses; may act as primary customer interface representing the department at client meetings; may present status updates at Senior Management meetings. • 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. • Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets. • 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; may include 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 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. • Proposes and leads the development of process improvements, clinical programming tools for standardization and efficiency, and the development of new concepts, technologies and products to meet emerging customer needs. • As required, oversees program level clinical programming operations by providing supervision for a team of clinical programmers, including professional development, performance appraisals, workload assignment, and conflict resolution. • Performs other work-related duties as assigned. • Minimal travel may be required.

🎯 Requirements

• Bachelor’s degree, Master’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and experience. • The ability to deal effectively with sponsors and internal customers at all levels. (Senior LT stakeholder management). • 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. (Good project management skills). • Experience working in a matrix-structured environment is preferred. • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail. • Python / SAS and clinical data expertise. • Sound knowledge of medical or safety review dashboards or listings. • SDTM and Veeva data knowledge is preferred. • No hands-on required, but should have a good understanding of the systems, tools, processes, data flows, and technicalities involved in carrying out system/tool migrations. • Experience in mentoring others in clinical trial process. • Ability to read, write, speak and understand English.

🏖️ Benefits

• career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program • Total Self culture – where you can authentically be yourself • dedicated to taking care of our people • training classes and attendance at professional meetings • comprehensive resources including emerging technologies, data, science and knowledge sharing • diversification and breadth creating a multitude of career paths and employment opportunities • minimal travel may be required • provision of reasonable accommodations under the Americans with Disabilities Act