Job Information
Sage Therapeutics Clinical Systems UAT Consultant in Remote, United States
General Scope and Summary
The Clinical Systems UAT Consultant role will serve as a GxP clinical systems expert and resource who collaborates with clinical study teams in the testing, implementation, and maintenance of electronic systems used in Sage-sponsored clinical trials. This position will ensure that each vendor-configured clinical system meets and maintains regulatory compliance and ensures the following: protocol adherence, participant safety, data integrity, product quality, and Sage intent of use.
Roles and Responsibilities
Responsible for collaborating with Clinical Study teams, inclusive of Clinical Operations, Data Management, Clinical Supply, and QA IT to establish and implement UAT timelines and expectations, including UAT assessment, testing, and full UAT documentation for clinical system implementations and updates.
Work with external service providers, ensuring that system requirements, test environments, test equipment, and training are available for the facilitation of end user/sponsor UAT.
Leveraging approved User Requirement Specifications and testing environments/equipment, develop test scripts, train end users, facilitate UAT, compile UAT results, and facilitate final review and approval of UAT documentation, so that system Go Live dates can be achieved per the established timelines.
Facilitate and lead change control and UAT impact assessments as warranted.
Maintain effective communication with all involved stakeholders. Proactively escalate issues or trends to leadership.
Attend departmental and study-specific meetings as required, which occasionally may be in-person.
Write/revise standard operating procedures, create templates and forms, and provide training. Drive a culture of compliance and continuous growth specific to clinical system qualification and maintenance.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic recommendations, action plans, and process improvements. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Basic Qualifications
BS/BA degree.
8+ years of pharmaceutical or biotechnology industry experience or equivalent.
Preferred Qualifications
10+ years of pharmaceutical or biotechnology industry experience or equivalent.
Extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of clinical systems UAT.
Agile and Self-motivated.
Detail-oriented with a flexible and solution-oriented outlook.
Specialization in GxP computer system validation and attaining regulatory compliance for clinical systems used in clinical trials.
Experience in developing business specifications/requirements, test scripts, and user acceptance testing for GxP computer systems.
Proven experience with vendor management and oversight.
Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and to drive projects to consistently meet deadlines.
Excellent planning, organizational, and time management skills, including the ability to support and prioritize multiple projects, both working independently and within a team.
Flexibility to adapt to the dynamic needs of a growing biotech company and to manage change effectively.
Ability to learn quickly and adjust approach to problems based on feedback.
Demonstrated experience working in a matrix environment.
Strong team player that has a customer service approach and is solution oriented.
PC literacy required, including fluid use of common MS applications.
Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Excitement about the vision and mission of Sage.
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