Principal Clinical Systems Analyst

Summary

Join Penumbra as a Principal Clinical Systems Analyst T and become a change agent, leading clinical systems projects and programs. You will leverage your expertise in clinical systems to support best clinical practices, collaborating with stakeholders, vendors, and internal teams. This role requires strong Medidata Rave EDC programming and Veeva Vault configuration experience. Responsibilities include planning, executing, and implementing clinical systems projects, ensuring system reliability, and providing end-user training. You will also act as the main contact for vendors and actively participate in strategic assessments. This position offers a collaborative environment and a generous benefits package.

Requirements

• Bachelor's degree in life science, computer science, engineering, business, health administration, health care or related field with 12+ years of related clinical systems experience in the medical device/biotechnology/pharmaceutical industry is required, or an equivalent combination of education and experience
• 3+ years of programming experience in Medidata Rave EDC and Veeva Vault configuration experience, or another EDC development/programming/integration platform is required
• Experience in development, implementation, training, support, and maintenance of clinical systems (e.g., CTMS, EDC, IVRS, imaging, or other related technology) is required

Responsibilities

• Serve as the clinical systems analyst on multiple studies to provide solutions for assigned clinical systems
• Possess extensive technical knowledge of assigned system technology and provide expertise and lead projects developing and implementing key clinical systems
• Work with clinical stakeholders to understand the requirements and workflow, and translate them to technical design specifications for vendors
• Serve as implementation lead with system vendors and clinical study team during the system build/ configuration, including scoping of the required effort and defining timelines
• Collaborate with Software Quality in the development and review of system-level test plans
• Serve as primary study interface with vendors regarding project status, budget, scope and issues
• Maintain an awareness and understanding of technological advances, vendor product offerings and issues, and drive enhancement requests to our vendor partners
• Identify opportunities for process improvements including promoting efficiency, quality, and establishing and maintaining standards
• Continually evaluate system performance and system functionality, including identifying and tracking study-related technical issues to resolution
• Maintain accurate documentation and communicate to internal and external parties as appropriate on system maintenance, upgrades, and downtime
• Proactively communicate to management, other analysts, subject matter experts, study teams, and end users to establish productive working relationships on systems topics including issue escalation, priority setting, solutions review, and knowledge transfer
• As an expert in clinical system functionalities, plan, manage and deliver end user training to groups or individuals, as needed
• Participate in strategic assessments and recommend solutions
• Establish, manage, and report vendor monitoring, system performance, and process key performance indicator’s (KPI’s)
• Lead activities related to setting standards, best practices, KPIs collection, developing new procedures and work instructions, and lessons learned dissemination
• Main contact with vendors and service providers on systems related issue resolution, maintenance and upgrades
• Lead activities related to upgrades and maintenance of clinical systems
• Proactively communicate information to management and study team, including timely notification to all appropriate parties with deviations from timelines and/or deliverables
• Responsible for communicating system status and maintenance activities and liaise with IT and vendors on extended support, hyper care, business continuity and disaster recovery
• Assist other teams as necessary in study-level test plans and user acceptance testing
• Monitor the development of new regulatory requirements or guidance, and provide advice of the impact on the business
• Actively identify, manage, and mitigate any project risks in a collaborative approach with other SMEs and the clinical study teams
• Performs other related duties as assigned or directed in order to meet the goals and objectives of the department
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
• Ensure other members of the department follow the QMS, regulations, standards and procedures
• Perform other work-related duties as assigned

Preferred Qualifications

• Strong familiarity with clinical operations and working knowledge of the software development lifecycle, testing methodologies, software system validation process, and compliance concepts
• Robust relationship-building and influencing skills coupled with exceptional interpersonal, verbal, and written communication skills and the ability to express oneself clearly and concisely to a variety of audiences
• Thorough knowledge of GxP, Annex 11 and 21 CFR Part 11 computerized systems
• Notable leadership skills with the ability to lead cross-functional and cross -regional teams while managing and delegating work as part of a team
• Must have ability to recognize problems, establish priorities, and initiate appropriate responses
• A critical thinker with effective time management, project management and organization skills, and the ability to analyze and solve a range of simple and complex problems
• Previous vendor management experience and the ability to successfully negotiate and collaborate with others of diverse backgrounds and levels

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s)