Provide overall Veeva Platform Management to holistically support Veeva across Penumbra’s various functional groups including Clinical Research, Marketing, Regulatory, Finance, and Quality. Support a portfolio of post market, industry standard solutions and regulatory clinical trial electronic systems by responding to and resolving end user application issues, advising on design decisions and delivering clear communication and documentation of complex concepts related to applications, interfaces, data structures, and workflows across the organization. This role will include technical database design and related systems setup, associated programming, development of listings/reports, validation, and documentation. As a technical resource, this position will be expected to support relevant internal and external users for Electronic Data Capture (EDC) and other clinical databases, reporting, and processing tools
What You’ll Work On
- Vendor Management: Work with Veeva to outline a roadmap and strategy management for Veeva use within relevant internal key stakeholder groups.
- Provide leadership and guidance for SaaS Platforms within Penumbra including but not limited to Veeva, and other regulatory systems.
- Engage providers in use and adoption of clinical systems, including new functionality and workflows.
- Oversee day-to-day clinical programming operations, including managing programming deliverables and Integration platforms.
- Lead and complete database build activities for EDC studies and related setup tasks including eCRF/study design, edit check programming, coding setup, external data import setup, and report development.
- Participate and lead the training and development of junior staff within the team.
- Participate and lead in all compliance audits related to assigned systems.
- Configuration of Veeva as per various key functional group’s business needs
- Advanced trouble shooting, break fix for issues spanning Veeva and related requirement
- analysis, effort estimation and solution/technical design for enhancements.
- Maintain awareness of global regulatory developments relevant to clinical systems and ensure that colleagues are kept informed.
- Serve as subject matter expert, clearly communicating technical concepts in business terms.
- Lead software upgrade initiatives, rapid configuration, testing and implementation of
- Veeva applications to support clinical trial with the Vault EDC, eTMF, CTMS platforms.
- Perform impact analysis and risk assessment on all proposed application changes.
- Participate in departmental process development initiatives by working closely with all stakeholders including Data Managers, Project Managers, Statisticians, Safety, Field Clinical Managers, Clinical operations (CTCs, CRAs, Study Managers) and other staff as required.
- Take the lead on implementation of improved programming processes and methods
- Participate in Electronic Case Report Form design and review, Edit Check specification and review
- Manage Veeva Vault configuration for existing releases and future Veeva releases
- Support Veeva Vault integration, to implement data cleaning specifications (e.g., required fields, range checks, data type checks, and within-and across-record logic checks) using SQL-based language
- Collaborate with Clinical Study Teams to identify additional data cleaning requirements based on commonly identified issues and feedback from participating sites
- Work with end users during the lifecycle of an implementation leading requirements workshops, gap analyses, requirements gathering, configuration, validation, migration, integration, training, and go-live activities
- Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
- Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
- Ensure other members of the department follow the QMS, regulations, standards, and procedures.
- Perform other work-related duties as assigned.
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What You’ll Bring
- Bachelor’s degree in engineering, computer science, mathematics or a related field with 8+ years of related experience or equivalent combination of education and experience
- At least 5+ years of experience in clinical research, including working knowledge of core clinical data management applications such as CTMS, EDC, eTMF, and Imaging
- Certified Veeva Administrator, and strong development experience with the Veeva Platform, and knowledge of computer systems validation in a SaaS environment
- Experience and knowledge of Software Development Life Cycle (SDLC)
- Demonstrated problem solving skills and technical knowledge required to diagnose, prioritize and remediate issues
- Excellent written, oral, presentation and interpersonal communication skills
- Ability to analyze highly complex systems and workflows; and to conceptualize, plan, and manage outputs
- Medical device, pharmaceutical, biotech, or other regulated industry experience required
- High degree of accuracy and attention to detail
- Proficiency with MS Word, Excel, and PowerPoint
- Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Working Conditions
- General office environment. Business travel from 0% – 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
- Alameda, CA
- Starting Base Salary is $97,864/year – $145,760/year.
- Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.
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.