Director, Clinical Systems and TMF Operations

at  Insmed Incorporated

Company Description:
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:
Named Science’s Top Employer in 2021, 2022, and 2023
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.

• Provides leadership and expertise to build and deliver CS+T strategy and initiatives to support organizational business objectives.
• Develops business cases around clinical systems & technology, implements solutions, and measures effectiveness.
• Partners with cross-functional team members (e.g., Development Operations, Data Management, Tech Ops/Clin Supplies, QA, IT, Procurement) to identify and select CS+T supplier(s), and ensure effective onboarding and implementation (e.g., qualification, Computer System Validation (CSV), system specifications, UAT).
• Responsible for oversight of the CS+T vendors (e.g., IRT/RTSM, eCOA/ePRO) and ensuring both quality and timeliness of their work.
• Identifies areas of opportunity, mitigates risks, and provides solutions to identified problems.
• Oversees contracting and budget management activities including establishing initial Scope of Work (SOW) and Change Orders, as applicable.
• Ensures all QA CSV requirements are met to support system validation and vendor qualification according to Insmed requirements, and per study start-up timelines.
• Supports/Oversees kickoff meeting(s) for each respective trial with the system/technology supplier and internal cross-functional team members.
• As Business Owner, ensures processes, tools, documents, and training materials related to clinical systems and technology are developed and implemented, as appropriate.
• Acts as primary business change agent within Development Operations to ensure adoption of new capabilities and business processes related to clinical systems and technology.
• Serves as an escalation point for study teams to drive resolution of issues, as appropriate.
• Oversees staff and supports activities related to system builds and implementation, as needed (e.g., writing and/or executing UAT scripts)
• Ensures completion of system deliverables within established timelines