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 on technical and operational sample-related questions and/or escalations across multiple study protocols
• Responsible for providing timely updates and coordination of sample movements needed for analysis or long-term storage to key collaborators including Development Operations and the Clinical Study Teams
• Support ongoing tracking, inventory reviews and work with the appropriate collaborators to obtain approvals for disposal/transfer of bio-samples in long-term storage or biobanking facilities
• Support development and updates of SOPs and guidance documents to support bio-sample management activities
• Work cross-functionally with collaborators to identify when a process revision is required
• Support management of bulk supplies including reagents for site processing of bio-samples
• Provide related documents for filing in the TMF. Work with eTMF team to resolve any issues/questions
• May assist the Clinical Study Team with the management of clinical supplies and equipment distribution to clinical sites, including coordination with internal and external collaborators as necessary
• May work directly with clinical sites to answer questions, train, and serve as liaison with vendor(s) to ensure issues are advanced and addressed thoroughly and quickly
• May manage internal inventory storage and usage of clinical samples
• May oversee other specialty vendors to support the identification of gaps in processes

Requirements:

• Bachelor’s degree with 5+ years of experience working in clinical research setting with a Sponsor/CRO company required
• Minimum of two (2) years’ experience within a sample management function at a Sponsor or CRO
• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials required
• Experience in clinical trial conduct in multiple phases of development across several therapeutic area preferred
• Strong leadership and project management skills, demonstrate flexibility and agility working within a multi-functional, global matrix
• Must have excellent communication skills (verbal and written), and good interpersonal/group skills
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
• Self-motivated with the ability to work effectively in a dynamic, sometimes ambiguous, environment
• Strong leadership with demonstrated ability to interface with senior leaders
• Ability to effectively manage multiple priorities with a sense of urgency!
• Roll-up-your-sleeves orientation and a strong ability to work in a team-based environment

Travel Requirements

Up to 10% travel

 

This role can be remote-based

 

#LI-Remote

Salary Range

$119,000 - $167,267 a year

Compensation & Benefits

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

 

 

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.