Principal Clinical Systems Analyst (Temporary Position)
General Summary
Under general supervision of the Manager of Clinical Systems or higher, the Principal Clinical Systems Analyst T is an expert in clinical systems and acts as a change agent to promote adoption of new processes and technologies to support best clinical practices. This position is responsible for leading the planning, coordination, execution, control, implementation and completion of clinical systems projects and programs. The position supports and has a key role in business analysis and implementation of changes and new processes and has solid understanding of business change management principles. This position assists with developing new capabilities, ensuring the reliability of systems, and completing new projects within schedule. The position will also have direct daily contact with global users supporting their efficient and compliant use of the clinical systems, be the main contact with vendors and service providers on systems related upgrades and issues, and and will mentor members of the clinical department. We are actively interviewing applicants with strong Medidata Rave EDC programming and Veeva Vault configuration experience.
Specific Duties and 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
*Indicates an essential function of the role
Required Qualifications
•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
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
Working Conditions
•General office environment
•Includes approximately 10% travel to conferences and/or other Penumbra affiliated facilities
•Requires some lifting and moving of up to 5 pounds
•Must be able to move between buildings and floor
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day
•Must be able to read, prepare emails, and produce documents and spreadsheets
•Must be able to move within the office and access file cabinets or supplies, as needed
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis
Temporary Pay Range Per Hour: $75.00 - $100.00
This is the the pay range for a B market. If hired in another market, the pay range will be different. Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
•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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
