Consultant - RTSM Services
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.
The Role
Veeva RTSM is changing the way clinical trial is managed in the industry. RTSM supports randomization and drug supply management with better product and services. The days of complex implementation and study conduct are gone; now research teams can make faster and more informed decisions.
What You’ll Do
- Review protocols and include required modules in the User Requirements Specification (URS)
- Perform highly skilled duties such as creating, reviewing, coordinating, and managing a variety of deliverables (including, but not limited to, timelines, KOM, URS, Communication Manual, Requirements for Subject Randomizations, and Clinical Trial Material Lists for assigned projects, User Acceptance Testing, and system set up)
- Ensure established timelines are met
- Facilitate and troubleshoot any issues associated with managing the delivery of RTMS systems
- Provide technical advice and assistance to other project managers, developers, validation, and customer support staff
- Configure the RTSM based on customer requirements
- Lead design review meetings with customers
- Provide RTSM expertise and guidance in the RTSM design
- Manage and configure data integration solutions
- Facilitate and troubleshoot the myriad of issues associated with designing complex systems and projects
Requirements
- Four-year degree or equivalent experience
- 2+ years of experience within the Clinical Trial Industry
- Ability to take the initiative and work proactively
- Superior organizational and communication skills
- Working Knowledge Microsoft Office
- Proven ability to work independently in a dynamic, fast-paced environment but also as part of a team
- A logical approach to problem-solving and an excellent eye for detail
- Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results
- Excellent verbal and written communication, interpersonal, and presentation skills
Nice to Have
- Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation
- Working understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH).
- Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies
- Life Science, computer science or related degree
- Familiarity with CDISC, ODM and other data management industry standards
- SaaS/Cloud experience in the delivery of clinical trials
- Experience with training for clinical sites and at investigator meetings
- Consulting experience
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.