Precision Medicine Study Operations Lead

Regeneron

Uxbridge

Hybrid

GBP 110,000 - 140,000

Full time

14 days+

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Job summary

Regeneron is seeking a Manager, Precision Medicine Clinical Laboratory Study Management to lead a team of CLSMs across therapeutic areas, driving precision medicine operational execution and biomarker strategies.

You will partner with the Precision Medicine Strategy Lead, clinical study teams, data management, SKDL, CLSM, and CLPM to deliver high-quality samples and data, enabling translation of innovative science to medicines for patients.

Qualifications

Bachelor's degree with a minimum of 8 years of pharmaceutical experience in matrix interaction.
Minimum of 5 years' experience with Clinical Trials, focus on clinical sample collection.
Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.

Responsibilities

Build lab database to address clinical trial sample collection needs, kits, testing and logistics.
Monitor’s acquisition of clinical trial samples and ensure compliance with ICF permissions.
Support clinical study teams for all technical and operational sample-related matters, liaising with stakeholders on ICF/documents.
Collaborate with central/specialty lab project managers, clinical trial management, and CRO to ensure samples are collected per protocol.
Oversee study start up, closeout and lifecycle activities for assigned studies at central/specialty labs.
Provide input on sample-related sections in protocols and ICFs and other supporting documents.
Work with data management and SKDL to determine data capture, blinding, and transfer for trials.
Enable transfer of sample/testing data from vendors through data transfer specifications.