Senior Manager, Bio-Sample Operations

Insmed Inc. • Bridgewater, NJ • 5h ago

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:We're looking for a Senior Manager, Bio-Sample Operations. As a member of the Clinical Business Operations team within Development Operations you will serve as the operational lead for clinical sample integrity, managing the full lifecycle from collection to disposition. This role provides strategic day-to-day oversight of central and specialty laboratories, ensuring compliance with study protocol and Informed Consent Forms (ICFs) requirements for safety and biomarker samples across a portfolio of studies.What You'll Do: In this role, you'll have the opportunity to oversee vendor selection, management, and performance for central safety (and specialty) laboratories ensuring high-quality, on-time delivery.You'll also: Provide technical and operational leadership for clinical study teams regarding laboratory oversight and bio-sample operations. Manage directly and/or through oversight of vendors/contractor(s), the end-to-end lifecycle of bio-samples, including collection, logistics, processing, analysis, data cleaning, and final disposition. Review of critical study documents, including Informed Consent Forms (ICFs), study protocols and CRO Clinical Laboratory Specifications (CLS) ensuring feasibility and alignment of sample collection procedures. Responsible for acting as the Translational Bioanalytical Science (TBAS) group's central point of contact for operational issues, proactively addressing potential quality issues with biomarker sample processing and/or shipment. Partner with cross-functional teams (Clinical Trial Operations, Clinical Development, Bioanalytical Sciences) to resolve sample-related informed consent and ethical queries. Oversee end-to-end clinical sample logistics, including the management, distribution, and tracking of lab kits and supplies to sites, coordinating with internal teams and external vendors. Oversee chain-of-custody and sample accountability from collection through analysis and long-term storage to ensure compliance with GxP and ICH/GCP guidelines. Provide direct support to investigational sites, including training on lab procedures, troubleshooting issues, and rapid escalation resolution. Resolve bio-sample data reconciliation issues by collaborating with Data Management and CRO partners. Contribute to CRF development to ensure accurate laboratory sample data collection, tracking, and reconciliation.Who You Are:You have a Bachelor's degree along with a minimum of 6 years' experience working in clinical research setting with a Sponsor/CRO company required.You are or you also have: Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials is required. Experience in clinical trial conduct in multiple phases of development across several therapeutic areas preferred. Strong leadership and project management skills, demonstrated flexibility and agility working within a multi-functional, global matrix Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Roll-up-your-sleeves orientation and a strong ability to work in a team-based environment Must successfully exhibit Insmed's five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any othe

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