Manager, Bio-Sample Operations

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

 

Consistently Ranked Science’s Top Employer

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’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

The Manager, Bio-Sample Operations is a member of the Clinical Business Operations group within Development Operations. The role is responsible for supporting the oversight of the complete lifecycle of bio-samples in clinical trials including but not limited to tracking of samples, ensuring that samples are collected, processed, stored, and disposed of in accordance with study Protocols, Informed Consent Forms (ICFs), and relevant laboratory documents. This role involves the management and oversight of central labs, specialty labs, and a variety of responsibilities associated with sample management across all clinical programs, including some clinical operations activities in the context of sample collection education and compliance at clinical sites.

Responsibilities

• Responsible for oversight of central labs and the lifecycle of bio-samples (e.g., collection, shipping, processing, analysis, data cleaning and delivery, long term storage, biobanking, and final sample disposition) across various programs to ensure sample integrity and compliance
• In collaboration with the Clinical Study Team, support selection of vendors for services such as central labs and some specialty testing labs (e.g., gene therapy, biomarkers)
• Oversee CRO partner sample management activities per study including sample tracking, site escalations, query resolution, and data reconciliation
• Review laboratory specifications for database design and setup to ensure protocol compliance and efficient logistics workflow
• Ensure sample integrity & traceability during transport and troubleshoot issues affecting sample integrity with the Clinical Study Teams and relevant external vendors
• Support resolution of informed consent and IRB/EC questions related to bio-samples in collaboration with Development Operations and the Clinical Study Teams
• Ensure samples are collected, applied, stored, or disposed of in accordance with the Protocol and Informed Consent Forms (ICFs) associated with each study.
• Oversee the logistics and tracking of sample shipments from clinical trial sites to central laboratories or third-party CRO
• Represent Development Operations as bio-sample management Subject Matter Expert to identify areas of potential opportunity, risk mitigation, and implement solutions to identified problems
• Participate in investigator meetings, kick-off meetings, monitoring training, and various vendor meetings
• Provide input and review of study documents that pertain to bio-sample collection, handling, and storage including clinical study protocols, ICFs, and lab manuals
• Assist bio-sample management leadership with execution of forward-thinking strategies and initiatives to support organizational business objectives (e.g., building out a biobank, sample tracking database)
• Support resolution of bio-sample related data reconciliation issues at sites and/or labs in collaboration with relevant collaborators such as Data Management, Development Operations and CRO partners
• Support Clinical Study Teams