Senior Clinical Trial Associate

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.

• Works with global cross‐functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines, government regulations, etc.
• Provides operational support for the Clinical Operations team with heavy focus on study start‐up activities, patient recruitment efforts, maintenance, and study closure deliverables.
• Participates in the creation and distribution of study materials, including essential documents, presentations, and reports.
• Assists with the tracking and documenting of site and sponsor training (e.g., study specific, drug, program, and therapeutic area level), and maintains training matrices for the clinical study team.
• Actively participates in clinical study team and vendor Schedules meetings, drafts and finalizes meeting agendas and action items. During clinical study team meetings, provides updates on health and currency of study TMF, and document tracking and currency, tracks and maintains cohesive list of protocol deviations.
• Reviews CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical Provides cross‐ functional support for inspection readiness preparations. Helps coordinate the retrieval of documents and coordination of other activities, as necessary.
• Participates and helps maintain study operations planning, risk assessment and mitigation strategies, and reviews and helps ensure level of detail and adherence to study’s RACT tool.
• Responsible for the QC activities of the Sponsor‐ and CRO‐supported TMF at intervals specified in project plan and/or applicable SOPs and/or prior to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.
• Responsible for the collection of essential documents and maintenance of both paper and electronic Trial Master
• Follows up with CROs, and/or functional area representatives on pending/outstanding documentation in accordance with TMF metrics.
• Assists in preparing TMF Health Reports and collecting TMF status updates and TMF metrics
• Participates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and other site/vendor Assists in the review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.
• Assists with the training and mentoring of newly hired CTAs, as appropriate