Associate, Clinical Trial Operations

Insmed Incorporated • NJ Corporate Headquarters, NJ

1d • $87,000 - $111,000 • Remote

About The Position

We’re looking for an Associate, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Clinical Trial Operations, you’ll assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.

Requirements

• Bachelor’s degree in life science, healthcare, or related field.
• 1+ year of experience in pharmaceutical/biotech industry.
• Experience in clinical research.
• Basic knowledge of Good Clinical Practice (GCP) and ICH guidelines in clinical trials.
• Good verbal communication and writing skills.
• Good interpersonal/group skills.
• Ability to demonstrate flexibility, agility and working within a multi-functional, global matrix.
• Demonstrated efficiency with multi-tasking and prioritization.
• Collaborative approach to process development, issue resolution/risk management.
• Roll-up-your-sleeves orientation and a strong ability to work in a globally team-based environment.

Nice To Haves

• Experience with TMF, both paper and electronic (eTMF) preferred.

Responsibilities

• Collection of trial-related documents and maintenance of both paper and electronic Trial Master File (TMF).
• Assist in periodic TMF quality control checks through the course of study as defined by the clinical study team, per ICH/GCP requirements.
• 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 assist with performing audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.
• Participate in the review of clinical trial agreements, work orders, and other site/vendor agreements.
• Assists in the review and processing of invoices related to study agreements.
• Assist with the tracking and documenting of site and sponsor training (e.g., Study specific, drug and program level).
• Participate in clinical study team and vendor meetings.
• Schedules meetings, drafts and finalizes meeting action items.
• During CST meetings, provides update on health and currency of study TMF.
• Assist in review of CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials.
• Assist in coordinating activities related to Regulatory Inspection (e.g., prep, retrieval of documents and other activities and support).
• Support Vendor audits, when needed.
• Process payments to vendors via Procurement system.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Annual wellbeing reimbursement
• Access to our Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups
• Service and recognition programs
• Meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level