Biosample Operations Manager 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.
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, bio sample 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 bio sample management.
Hybrid Working
At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. Hybrid work from certain locations may be permitted in accordance with Astellas\' Responsible Flexibility Guidelines.
Key Responsibilities
* Manage and coordinate study set up in 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 (or other quality document) development.
* Identify any training needs and participate in the development of any sustainable training materials required.
* 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.
Qualifications
* 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 (as applicable) of Bio sample 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.
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