BlueRock Therapeutics
Associate Director, Clinical Development Solutions, IT
BlueRock Therapeutics, Cambridge, Massachusetts, us, 02140
Sr Solutions Architect, Clin-Dev Solutions
will be the primary IT solutions owner to support BlueRock’s rapidly expanding Clinical Development organization. The successful candidate will 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. The candidate will co-develop & own product roadmaps, guide clinical development teams in the areas of industry best practices for technology solution implementation to improve business processes, be a constructive leader challenging status quo, be holistic thinker for time appropriate and risk appropriate solutions, own the system operations as well as increase efficiency and effectiveness in the way data is collected, stored, analyzed, processed, reported, and interpreted in compliance with industry expectations and regulations.This position will be responsible for the building, deploying, managing and continuous improvement of critical technology initiatives including but not limited to components of the elluminate data platform, SAS, Bayer enabled solutions for RIM/TMF etc., GxP SAS environment, and drug safety applications. In addition, this position will be responsible for oversight of clinical data management, process automation and integrations; will work collaboratively with teams of internal and external resources across system engineering, dev/ops, business systems analysis, program and project leads and IT on solution discovery, delivery, on-going development (continuous improvement) and operational support while achieving positive results through innovation in close collaboration with BlueRock’s Development user community.Responsibilities:
Partner with IT and Clinical Development leadership to develop and execute upon a shared vision and strategy for delivering innovative and efficient enterprise technology solutions and services for BlueRock’s user Community.Adhere to BlueRock’s IT architectural principles and standards across the enterprise, implements technology solutions for all facets of Clinical Development functions.Collaborate with teams of internal and external technical resources across Dev/Ops, systems engineering, business analysis, project management and IT/Application support.Create project and operational support documentation, which may include business requirement documents, process and data flow diagrams, solution design specifications, implementation plans and testing scripts, and reporting of results.Partner with application and solution engineers, performing solution/service architecture/code review.Manage the central administration and management of IT application and database service delivery and support, including system monitoring, ensuring data integrity and security in accordance with BlueRock’s security policies and compliance requirements and regulations.Excellent organizational and leadership skills; Outstanding communication and interpersonal abilities with demonstrated problem-solving and troubleshooting skills.Ability to work independently and exercise judgment with excellent attention to detail.Minimum Requirements:
9+ years of relevant experience listed belowRelevant Cert / College diploma and 7+ years of relevant experience listed belowBS/BA in life science, information technology or relevant field, with minimum 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.
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will be the primary IT solutions owner to support BlueRock’s rapidly expanding Clinical Development organization. The successful candidate will 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. The candidate will co-develop & own product roadmaps, guide clinical development teams in the areas of industry best practices for technology solution implementation to improve business processes, be a constructive leader challenging status quo, be holistic thinker for time appropriate and risk appropriate solutions, own the system operations as well as increase efficiency and effectiveness in the way data is collected, stored, analyzed, processed, reported, and interpreted in compliance with industry expectations and regulations.This position will be responsible for the building, deploying, managing and continuous improvement of critical technology initiatives including but not limited to components of the elluminate data platform, SAS, Bayer enabled solutions for RIM/TMF etc., GxP SAS environment, and drug safety applications. In addition, this position will be responsible for oversight of clinical data management, process automation and integrations; will work collaboratively with teams of internal and external resources across system engineering, dev/ops, business systems analysis, program and project leads and IT on solution discovery, delivery, on-going development (continuous improvement) and operational support while achieving positive results through innovation in close collaboration with BlueRock’s Development user community.Responsibilities:
Partner with IT and Clinical Development leadership to develop and execute upon a shared vision and strategy for delivering innovative and efficient enterprise technology solutions and services for BlueRock’s user Community.Adhere to BlueRock’s IT architectural principles and standards across the enterprise, implements technology solutions for all facets of Clinical Development functions.Collaborate with teams of internal and external technical resources across Dev/Ops, systems engineering, business analysis, project management and IT/Application support.Create project and operational support documentation, which may include business requirement documents, process and data flow diagrams, solution design specifications, implementation plans and testing scripts, and reporting of results.Partner with application and solution engineers, performing solution/service architecture/code review.Manage the central administration and management of IT application and database service delivery and support, including system monitoring, ensuring data integrity and security in accordance with BlueRock’s security policies and compliance requirements and regulations.Excellent organizational and leadership skills; Outstanding communication and interpersonal abilities with demonstrated problem-solving and troubleshooting skills.Ability to work independently and exercise judgment with excellent attention to detail.Minimum Requirements:
9+ years of relevant experience listed belowRelevant Cert / College diploma and 7+ years of relevant experience listed belowBS/BA in life science, information technology or relevant field, with minimum 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.
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