Senior Solutions Architect, Clinical Development Solutions
4 weeks ago
At BlueRock Therapeutics, we are seeking a highly skilled Senior Solutions Architect to join our Clinical Development team. As a key member of our IT organization, you will be responsible for designing and implementing innovative technology solutions to support our rapidly expanding Clinical Development organization.
Key Responsibilities:
- Own the product portfolio and related relationships with key stakeholders across the Clinical Development functions
- Integrate, develop, and deliver innovative and efficient technology solutions and services resulting in business process efficiencies
- Co-develop and own product roadmaps, guiding clinical development teams in the areas of industry best practices for technology solution implementation to improve business processes
- Be a constructive leader, challenging the status quo, and a holistic thinker for time-appropriate and risk-appropriate solutions
- Own the system operations, increasing efficiency and effectiveness in the way data is collected, stored, analyzed, processed, reported, and interpreted in compliance with industry expectations and regulations
Requirements:
- BS/BA in life science, information technology, or a relevant field, with a minimum of 6 years of relevant experience in IT engineering, solution, or technical architecture and/or business experience in pharmaceutical, medical device, or biotechnology field supporting Clinical Development and Medical affairs technologies
- Extensive experience in collaborating with Clinical Development and other stakeholders across all levels and disciplines
- Proven ability to lead business/IT teams responsible for implementing, enhancing, and supporting Clinical Development software tools/technology, including Veeva Vault Clinical Suite, SAS, elluminate, and Clinical Data Management Systems (CDR)
- Experience in a Clinical Development IT consulting, interfacing with leadership/business teams providing guidance and/or advisory services in the areas of systems and solution identification, selection, implementation best practices, and overall system life cycle management
- Proven experience leading application life cycle management best practices, ensuring regulatory compliance; support system validation/testing (GxP, Part 11, Privacy, etc.)
- Knowledge of controlled computer system environments supporting corporate audit and/or regulatory inspection readiness, data integrity controls
We are an equal opportunity workplace and welcome diversity and inclusion. If you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process, please let us know so that we can work with you to meet your needs.
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