Jobs and Careers
PE
Principal Clinical Systems Analyst (Temporary Position)
PenumbraUnited Statesfull_timeVerifiedPosted 20 Dec 2024
💰 $200,000/yr($150,000/yr – $200,000/yr)
About the role
General SummaryUnder 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 keyperformance 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 qualitysystem 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
<
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 keyperformance 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 qualitysystem 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
<
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s