Associate, Clinical Trial Operations

Role Summary

Associate, Clinical Trial Operations on the Clinical Operations team supporting delivery of Clinical Operations objectives by providing operational support to the clinical study team and managing multiple trials across all phases. Ensures compliance with SOPs, FDA regulations, GCP and ICH guidelines. This is a hybrid role.

Responsibilities

• Work with cross-functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines and government regulations.
• Be responsible for the collection of trial-related documents and maintenance of both paper and electronic Trial Master File.
• Assists in periodic Trial Master File quality control check through the course of study as defined by the clinical study team, per ICH/GCP requirements.
• Be 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 assist with performing audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.
• Follow up with CROs and functional area representatives on outstanding documentation in accordance with TMF metrics.
• 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).

Qualifications

• Required: Bachelor's degree and a minimum of 2+ years of experience in pharmaceutical and/or biotechnology industry, and experience in clinical research.
• Required: Basic knowledge of Good Clinical Practice (GCP) and ICH guidelines in clinical trials.
• Required: Good verbal communication and writing skills, and good interpersonal/group skills.
• Required: Ability to demonstrate flexibility, agility and working within a multi-functional, global matrix.
• Preferred: Experience with TMF, both paper and electronic (eTMF).
• Preferred: Demonstrated efficiency with multi-tasking and prioritization.
• Preferred: Collaborative approach to process development, issue resolution/risk management.
• Preferred: Roll-up-your-sleeves orientation and a strong ability to work in a globally team-based environment.
• Required: Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.