Astellas Pharma - Biosample Operations Manager
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About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under‑served disease areas and in life‑threatening or life‑limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword – it’s a guiding principle for action. We believe all staff have a role to play in creating a patient‑centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real‑world evidence to inform the best decisions for patients and their care‑givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
Description
Biosample Operations Manager
The Opportunity
As a Biosample Operations Manager, your role is pivotal in planning, initiating, and executing biosample management activities. The position includes vendor management, training, and effective interactions with study teams, as well as process development and improvement, biosample operations system administration, and sample tracking activities. Responsibilities are to be performed independently with minimal guidance from supervisors. You are responsible for all operational activities associated with the implementation and maintenance of studies in the sample management system. Additionally, the BOM acts as a resource for best practices in biosample management.
Key Responsibilities
* Manage and coordinate study setup in the Sample Management system.
* Act as liaison between study team, Sample Management vendor and Bio sample vendors.
* Monitor study build and rollout according to timelines.
* Support the maintenance of any associated quality documents relative to biosample management to ensure they are kept current and accurate.
* Contribute to various Medical & Development process improvement initiatives and SOP (Standard Operating Procedure) development.
* Identify any training needs and participate in the development of sustainable training materials required.
Essential Knowledge & Experience
* Proven experience in pharmaceutical, clinical research or health services industry with a minimum of experience as clinical study manager, central laboratory project manager, data manager, or project manager.
* Working knowledge of GCP (Good Clinical Practice), FDA (Food and Drug Administration) and/or EU Clinical Trials Directive guidance documents.
* Experience with protocol and clinical drug development processes.
* Proven project management skills and leadership ability.
Preferred Knowledge/Experience
* Experience with Bio sample Tracking/Management preferred.
* Ability to integrate and apply GCP, clinical operations, and scientific knowledge in the planning, management, data review, and reporting of biosample related data. Ability to read and understand clinical protocols and related documents, especially with regard to collection, processing, storage, and shipment of critical specimens.
Education
* Bachelor’s degree in science or equivalent.
Additional Information
* Type of role: full time permanent.
* Location: UK (Addlestone).
* This position follows our hybrid working model. The role requires a blend of home and minimum 1 day per quarter in our UK office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
We Offer
* A challenging and diversified job.
* Opportunity and support for continuous development.
* Inspiring work climate.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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