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.
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
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
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
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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.