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General Summary:
Under general supervision, engages in the planning, design, and development of clinical systems at Penumbra, in order to ensure that those systems are maintained in compliance with Penumbra’s standards and regulatory requirements. Working in collaboration with data managers, clinical research staff, IT, and quality assurance staff, takes the lead on responding to and resolving end user application issues, addressing design decisions and delivering clear communication and documentation of complex concepts related to applications, interfaces, data structures, and workflows across the organization.
Duties and Responsibilities:
•Complete the build of clinical study databases from the study requirements specification and data validations specification.
•Generate summary report of clinical software validation activities.*
•Develop project timelines for clinical programming deliverables.
•Conduct clinical systems training for all users, including new clinical team members.*
•Participate in all compliance audits related to clinical systems.*
•Working with vendors and other stakeholders, develop strategies for fulfilling regulatory and quality requirements.
•Coordinate testing, validation, and upgrades of clinical system upgrades and interfaces. *
•Monitor application performance, including backups, replication, and data restore.
•Design and modify policies and procedures.*
•Serve as subject matter expert, clearly communicating technical concepts in business terms.*
•Lead software upgrade initiatives, new software installations and enhancements.
•Develop user feedback mechanisms.*
•Perform impact analysis and risk assessment on all proposed application changes. *
•Critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Review data entry screen designs and correct flaws proactively.*
•Collaborate with clinical team to develop user requirement specifications for clinical systems.*
•Communicate with selected vendors and/or build clinical systems to meet clinical user requirements. *
•Comply with quality system regulations, standards and procedures.*
* Indicates essential function.
Position Qualifications:
Minimum education and experience:
•Bachelor’s degree in computer science, engineering, mathematics, or a related field and 5+ (five+) years of database programming experience, or an equivalent combination of education and experience.
•Solid hands-on knowledge of at least one programming language (e.g. MATLAB, C Sharp, Visual Basic, SQL, Python) required.
•An understanding of the software development lifecycle process is required.
•1+ years of experience with Oracle Inform required.
•I+ years of experience working with EDC (electronic data capture) and a working knowledge of other core clinical data management applications (Clinical data management systems, query tools, web browser, MS Office suite) is required.
Additional qualifications:
•Relational database experience preferred.
•Experience with clinical databases such as Medrio, OpenClinica, or Veeva CDMS a plus.
•Experience with eCRF design is a plus.
•A team player with excellent written, oral and interpersonal communication skills as well as demonstrated organizational and problem-solving skills, keen attention to detail, and the ability to handle multiple projects simultaneously.
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 that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
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.