Clinical Systems Manager

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!
 

The Clinical Systems Manager is responsible for the implementation, validation, training, and end user support of clinical trials on the Clinical Trials Management System (CTMS) and the Electronic Trial Master File (eTMF). The incumbent will develop and execute project plans, identify, and provide training, plan for, and implement systems upgrades, validations, enhancements, and programming to meet business needs. S/he will also be responsible, in conjunction with the Project Managers and IT, to ensure that appropriate security measures are in place and adhered to in accordance to all Veristat, FDA, and other Regulatory Agencies.

As a Clinical Systems Manager You Will...
 

• Provide leadership for the development of the CTMS and eTMF capabilities of Veristat and adoption of those new features by Veristat workers and clients
• Coordinate and oversee all activities of the CTMS and eTMF including the implementation and maintenance of any system updates and new modules
• Work with users and software vendors identifying solutions for clinical needs and supporting the implementation, validation and implementation of those systems.
• Work with end users on identifying and resolving problems, working with software vendor as needed if required
• Support M&A Activities.
• Proactively prepare for and supports all Client Audit needs relating to the operational use of the systems
• Oversee the development and maintenance of an effective mechanisms to manage, track and report clinical trial information
• Handle all user administration within clinical systems including CTMS and eTMF including system configuration (some of this will transition as CM hires more people)
• Ensure the availability of on-going training modules and continuing education of end-users; coordinate and conduct training as deemed necessary
• Assist or create reports as required for reporting to project teams, Senior Leadership and others as requested; provide monthly reports from CTMS and eTMF for gap analysis
• Define parameters to measure output and performance standards
• Liaise with Project Management and Clinical Monitoring departments as required for study start-up, maintenance and closure
• Perform Software Validation and IT Change Order Activities as needed

• Liaise with Corporate Compliance to ensure all applicable CTMS and eTMF training has been completed by required users prior to granting access
• Liaise with appropriate functions to ensure that correct access rights are considered per study per role
• Responsible for access and role specific rights to the CTMS and eTMF
• Collaborate as needed on Controlled Documents related to CTMS, eTMF and other Clinical systems and capabilities with appropriate department leads.

Experience & Minimum Requirements:
 

• Bachelor’s Degree preferred
• 2-4 years related clinical systems work experience required, preferably in a CRO
• Prior experience with clinical systems including CTMS and eTMF software (including system setup and maintenance) required
• Strong communication skills required
• Strong computer skills required (Microsoft Office)
• Experience working with remote or geographically dispersed end-users required