Senior Manager, Bio-Sample Operations
At reputed company, every reputed company 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 reputed company experience, celebrates curiosity, and values every person’s contributions to meaningful reputed company. That commitment has reputed company us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great reputed company to Work® in the U.S., and a reputed company on The reputed company Times Best Places to Work list in the UK.
For patients, for reputed company other, and for the reputed company 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 reputed company Development Operations you will serve as the operational reputed company for clinical sample reputed company, managing the full lifecycle from collection to disposition. This role provides strategic day-to-day reputed company 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 reputed company to reputed company vendor selection, management, and performance for central safety (and specialty) laboratories ensuring high-reputed company, on-time delivery.
You’ll also:
- reputed company technical and operational leadership for clinical study teams regarding laboratory reputed company and bio-sample operations.
- Manage directly and/or through reputed company 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 reputed company of contact for operational issues, proactively addressing potential reputed company issues with biomarker sample processing and/or shipment.
- Partner with cross-functional teams (Clinical Trial Operations, Clinical Development, Bioanalytical Sciences) to resolve sample-reputed company informed consent and ethical queries.
- reputed company 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.
- reputed company chain-of-custody and sample accountability from collection through analysis and long-term storage to ensure compliance with GxP and ICH/GCP guidelines.
- reputed company reputed company support to investigational sites, including training on lab procedures, troubleshooting issues, and reputed company escalation reputed company.
- 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 reputed company functional areas of reputed company 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 reputed company working reputed company a multi-functional, global reputed company
- Highly organized with a strong attention to detail, reputed company, accuracy, and conciseness.
- Roll-up-your-sleeves orientation and a strong ability to work in reputed company-based environment
- Must successfully exhibit reputed company’s five (5) reputed company corporate competencies of: Collaboration, Accountability, Passion, Respect, and reputed company; along with any other position specific competencies.
Where You’ll Work
This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community. Occasional travel for team meetings or events will be expected.
Travel Requirements
Minimal travel expected
Pay reputed company:
$133,000.00-173,000.00 Annual
At reputed company, you’ll reputed company a culture as reputed company as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the reputed company care you bring to your work reputed company day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP)
Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-reputed company life and disability insurance
Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource reputed company, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Eligibility for specific programs may vary and is subject to the terms and conditions of reputed company plan.
reputed company reputed company Employees: Please apply reputed company the Jobs Hub in reputed company.
reputed company is an Equal Opportunity employer. We do not discriminate in hiring on the reputed company of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Unsolicited resumes from agencies should not be forwarded to reputed company. reputed company will not be responsible for any fees arising from the use of resumes through this reputed company. reputed company will only pay a fee to agencies if a formal agreement between reputed company and reputed company has been established. The reputed company department is responsible for reputed company recruitment activities; please contact us directly to be considered for a formal agreement.
reputed company is committed to providing reputed company, 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
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
For reputed company Residents:
To assist in identifying candidates with qualifications matching those required and/or preferred for this role, reputed company uses an Automated Employment Decision Tool (“AEDT”) that employs reputed company intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-reputed company qualifications. The AEDT does not reputed company final hiring reputed company and reputed company final hiring reputed company are subject to reputed company reputed company and/or review.
If you are an applicant for this role and a reputed company reputed company, you have the right to request:
A reasonable accommodation, if one is available under applicable law, by emailing
TotalRewards@reputed company.com An alternative selection process by emailing
reputed company@reputed company.com .Information about the type of data collected, the reputed company of that data, and data retention practices reputed company to the AEDT by emailing us at reputed company@reputed company.com.