Director, Clinical Systems and TMF Operations

$179,000 - $250,800/Yr

Insmed Incorporated - Bridgewater Township, NJ

Full-time - Senior

Bridgewater Township, NJ

Professional, Scientific, and Technical Services

About the position

The Director, Clinical Systems and TMF Operations at Insmed is a strategic leadership role within the Clinical Business Operations team. This position is responsible for overseeing Trial Master File (TMF) Operations, Records Management, and Clinical Systems & Technology (CS+T) across clinical programs. The director will ensure compliance with industry standards, optimize operational models, and foster a culture of continuous improvement while collaborating with cross-functional teams and external suppliers.

Responsibilities

• Provide leadership and expertise to build and deliver CS+T strategy and initiatives.
• Develop business cases around clinical systems & technology and implement solutions.
• Partner with cross-functional teams to identify and select CS+T suppliers and ensure effective onboarding.
• Oversee CS+T vendors to ensure quality and timeliness of their work.
• Manage contracting and budget activities, including establishing Scope of Work and Change Orders.
• Ensure all QA CSV requirements are met for system validation and vendor qualification.
• Support kickoff meetings for trials with system/technology suppliers and internal teams.
• Ensure processes, tools, documents, and training materials related to clinical systems are developed and implemented.
• Act as a primary business change agent to ensure adoption of new capabilities and processes.
• Oversee TMF Operations strategy and management within the Global Clinical Development organization.
• Develop and implement innovative strategies to enhance TMF and records management systems.
• Ensure TMF compliance with industry standards and regulations.
• Oversee quality control activities to ensure TMFs are inspection ready.
• Establish and enhance TMF metrics and implement support measures for improvement.
• Provide functional support for audits and inspections.
• Create and enhance standards for archiving and oversee adherence to processes.
• Provide functional leadership and strategic direction to the Clinical Systems and Documentation Management team.
• Evaluate industry changes and proactively identify recommendations for future capabilities.
• Manage and lead direct reports, including recruitment, training, and performance evaluations.

Requirements

• Bachelor's degree from an accredited college or university; advanced degree preferred.
• Minimum of 10 years of progressive experience in a TMF and/or Systems Management role with a Sponsor/CRO company.
• Experience managing staff is required.
• Experience with Veeva Vault Clinical eTMF system is required.
• Experience managing IRT/RTSM and eCOA/ePRO systems is required.
• Experience authoring/reviewing procedures in a GCP environment is required.
• Strong leadership and project management skills.

Nice-to-haves

• Experience in clinical trial conduct is a plus.
• Ability to develop, execute, and evaluate strategies to improve processes.

Benefits

• Flexible approach to work location and hours.
• Competitive compensation package including bonus.
• Stock options and RSU awards.
• Employee Stock Purchase Plan (ESPP).
• Flexible Vacation Policy.
• Generous paid holiday schedule and winter break.
• 401(k) plan with company match.
• Medical, dental, and vision plans.
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance.
• Short and long-term disability benefits.
• Unique offerings of pet, legal, and supplemental life insurance.
• Flexible spending accounts for medical and dependent care.
• Employee Assistance Program (EAP).
• Mental Health online digital resource.
• Well-being reimbursement.
• Paid leave benefits for new parents.
• Paid time off to volunteer.
• On-site, no-cost fitness center at U.S. headquarters.