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Project Manager, Clinical Medical Systems

Company: Integrated Resources INC
Location: Cambridge
Posted on: November 26, 2022

Job Description:

Job Description The Role: As a Digital Project Manager, you will be spearheading the execution of critical digital projects in support of Client's ambitious clinical digital roadmap. In this role, you will connect and lead various stakeholders and contributors to collaborate on digital clinical projects. This role will report to the Principal Project Manager, Clinical Informatics and be based in Cambridge, MA. Heres What Youll Do: Define and lead Digital Clinical, Medical & Regulatory Projects Coordinate and participate in requirement gathering and definition (Business Analysis) Establish and manage project timelines and project deliverable Ensure project goals and means meet business objectives and deliver value in a timely fashion Work collaboratively across the organization to Product alignment on project objectives and deliverables Engage with Computer Systems Validation lead to support appropriate validation activities Report on project progress and status Heres What Youll Bring to the Table: 7+ years' experience in digital project management in a GxP environment Proven experience with numerous Clinical, Medical Affairs Regulatory (Veeva preferred). Working knowledge of CSV concepts for SaaS GxP applications Tangible track record in using Agile approaches in a regulated environment As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of SaaS technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials. You have a working knowledge of clinical operations, clinical data management, regulatory and safety business processes in a drug development context You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward. You don't hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity and lead a team effectively You put team before tasks by collaborating actively with all team members and supporting them. Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.

Keywords: Integrated Resources INC, Cambridge , Project Manager, Clinical Medical Systems, Executive , Cambridge, Massachusetts

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