Senior Manager, Clinical Programming

The Senior Manager, Clinical Programming is responsible for strategic oversight, implementation, and support of clinical systems and the associated operational use of these systems as part of client engagements within the Data Services business unit. The Senior Manager, Clinical Programming will provide direction and manage staff associated with the various clinical systems in place as well as ensure the team provides quality deliverables on time and within budget. The Senior Manager, Clinical Programming must possess a thorough understanding of clinical applications and be able to apply technology to solve problems and enhance the experience of the internal and external system users.

KEY TASKS & RESPONSIBILITIES 

• Functions as a technical expert who provides management, leadership in the design, development, and delivery of any clinical applications and the associated services within the Data Services business unit
• Forecast and allocate resources that utilize the clinical systems as part of meeting client engagement commitments
• Ensure efficient use of systems and processes to increase revenue and improve P&L within elluminate services
• Design best practices to ensure fast, flexible, and high-quality decentralized clinical trial project execution
• Interfaces/interacts directly with clinical application vendors as required
• Act as a point of technical escalation and resolution during the project lifecycle as it relates to technical decisions within Biometrics Services
• Participates as functional SME and representative to acquire new business
• Ensures all clinical systems are being effectively and efficiently utilized to meet overall department organization goals
• Helps prepare documentation for clinical applications and all ancillary products as needed
• Ensures departmental quality and defines clear goals for continuous quality improvements
• Lead or contribute to development and maintenance of departmental standards, templates, and SOPs to contribute to innovation and implement change that will enhance the overall effectiveness of elluminate services 
• Recruits and hires employees who can help grow and drive departmental strategy and perform delivery on the services team
• Lead projects as Technical Lead (Clinical Programmer) when needed
• Other duties as assigned

Education & Experience 

• Bachelor’s degree or equivalent work experience preferred
• Excellent command of the English language (both written and verbal)
• 8+ years’ experience Pharmaceutical/Biotechnology/Medical Device industry preferred
• 5+ years’ experience of working with various clinical systems preferred
• 2+ years’ experience managing individual contributing staff 

Professional Skills 

• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Strong prior customer interface experience with a demonstrated ability to develop, maintain and grow strong relationships
• Proven ability to motivate and mentor technical staff resulting in a world-class delivery team 

Technical Skills

• A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first direct experience with multiple clinical trial systems such as Medidata Clinical Cloud, elluminate, Oracle/Phase Forward Inform, Veeva, SAS, Oracle IRT, IVRS, Analytics applications, JReview, Qlik, Coding applications, eSource, and other clinical technologies