About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas including oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we pioneer new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Job Description
Biosample Operations Manager
Location and Working Environment
This position is hybrid and will require you to be onsite once per quarter at our Bourne office, UK. Astellas’ Responsible Flexibility Guidelines allow hybrid work with time to connect with colleagues at the office and flexibility to work from home.
Purpose & Scope
We are looking for a dynamic Biosample Operations Manager to lead and execute biosample management activities with precision and impact. The role involves overseeing vendor relationships, providing training, working closely with study teams to drive process improvements, managing biosample operations systems, ensuring smooth sample tracking, and playing a key role in system administration.
Role And Responsibilities
* The Biosample Operations Manager (BOM) manages all operational aspects of study implementation and maintenance within the sample management system and serves as a key resource for biosample management best practices.
* Oversees study setup in the Sample Management system, liaises with study teams and vendors, ensures timely project rollout, provides system training, contributes to team discussions, and maintains lessons learned and evaluation documents.
* Supports maintenance of quality documents related to biosample management, keeps them current and accurate, updates Biosample Operations Work Instructions and Templates, and participates in vendor evaluations and technology or laboratory CRO selection.
* Contributes to process improvement initiatives and development of SOPs and other quality documents.
* Identifies training needs, develops sustainable training materials, and supports the ongoing review of materials to ensure they remain current and accurately reflect BSMO processes.
Required Qualifications
* Bachelor's degree or equivalent with scientific or clinical background; study management experience preferred.
* Solid experience in pharmaceutical, clinical research or health services industry, having worked as a clinical study manager, central laboratory project manager, data manager, or project manager.
* Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents.
* Experience with protocol and clinical drug development processes.
* Maintaining the BSMO SharePoint site.
* Proven project management skills and leadership ability.
* Excellent interpersonal, written, and verbal communication skills and computer proficiency.
Preferred Qualifications
* Experience with Biosample Tracking/Management.
* Ability to apply GCP, clinical operations, and scientific knowledge in planning, managing, reviewing data, and reporting biosample-related information.
* Skilled in reading and understanding clinical protocols, especially regarding collection, processing, storage, and shipment of critical specimens.
* Strong problem‑solving and critical‑thinking abilities, capable of identifying root causes and implementing corrective actions within GCP regulations, SOPs, protocols and industry best practices.
* Proactive thinking and anticipation of problems.
* Highly motivated, self‑directed, reliable, with strong presentation skills, ensuring content is clear and organized.
* Effective oral and written communication skills and excellent organization of tasks and project milestones.
What awaits you at Astellas
* Global collaboration: Join a connected global business of leaders dedicated to improving patient lives worldwide.
* Real‑world patient impact: Contribute to transformative therapies that reach patients globally.
* Relentless innovation: Shape the future of healthcare in a company at the forefront of scientific breakthroughs.
* A culture of growth: Build your own career path within a supportive environment that values contributions, champions development and empowers pursuit of passions.
Our Organisational Values and Behaviors
* Impact
* Innovation
* Integrity
* One Astellas
* Accountability
* Courage
* Sense of Urgency
* Outcome Focus
Benefits
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
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