Responsible for enhancing the Veeva Vault Platform to enable the success of stakeholders across the business via collaboration with cross-functional domestic and international colleagues. Responsible for the day-to-day administration, configuration, maintenance, and support of the Veeva Vault Platform in accordance with established Standard Operating Procedures (SOPs). Job duties:Perform day-to-day administration activities of Veeva Vault as per approved procedures. Oversight of managed services... more details
Responsible for enhancing the Veeva Vault Platform to enable the success of stakeholders across the business via collaboration with cross-functional domestic and international colleagues. Responsible for the day-to-day administration, configuration, maintenance, and support of the Veeva Vault Platform in accordance with established Standard Operating Procedures (SOPs). Job duties:
Perform day-to-day administration activities of Veeva Vault as per approved procedures.
Oversight of managed services to ensure that application configuration meets business requirements and is consistent with MicroVention standards.
Accountable for implementation/delivery of Veeva applications to meet business needs with a focus on regulated functions, including:
Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders.
Participate in the development of solutions and manage project/change timelines.
Liaise with key stakeholders to coordinate implementation activities.
Work with the business to develop system and user requirements.
Define and oversee documentation of configuration and design specifications.
Participate in the authoring and execution of implementation plans/qualification Test and computerized system validation documentation.
Management of system operations in Veeva including:
Control of system access and permissions.
Perform change management activities.
Design solutions and manage configuration.
Liaise with users to resolve issues.
Create reports based on defined requirements.
Maintain system documentation.
Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.
Identify and implement improvements (configurations, change management) based on user feedback and new business processes.
Responsible for maintaining system under change control and associated documentation supporting creation and revision of validation deliverables and the validated state of the application.
Responsible for Project setup, checklists, templates, training, and maintenance of system libraries.
Ensure consistent and accurate data flow within and among all clinical systems.
Provide data export or reports to project owners and study teams.
Partner with external service providers as necessary to support department goals.
Remain current on Veeva Vault updates, patches, and enhancements.
Assist in the evaluation of system usage and provide recommendations for operational efficiencies and continuous improvement.
Create study dashboards and reports.
Conduct data integrity checks/prepare for and support audit and regulatory authority inspection needs; escalate quality or compliance concerns as necessary to study and/or functional leadership.
Attend Monthly Global Governance meetings and represent MicroVention in new and ongoing initiatives.
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
Perform additional duties as assigned.
Bachelor’s degree in a related field, or equivalent combination of education and related experience.
Minimum six (6) years of direct clinical research experience preferably in the medical device industry.
Minimum two (2) years of experience in a Veeva Vault Administrator role.
Knowledge of FDA regulations and GCP/ICH guidelines for clinical trials and clinical procedures.
Strong collaborative skills with demonstrated ability to work with others within the company.
Experience using technologies for clinical research (electronic data capture and clinical trial management systems).
Excellent written and verbal communication skills.
General computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.).
Ability to shift priorities in line with business updates and adapt the implementation plan accordingly.
Desired Qualifications
Bachelor’s degree in Life Sciences preferred.
Clinical research expertise in various therapeutic areas, preferably Neurovascular and/or Cardiovascular.
Experience in the medical device industry.
Minimum two (2) years of project management experience.
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