Specialist, Biosample Operations - Contractor

Summary

The Specialist, Biosample Operations Contractor will assist Biosample Managers in planning, implementing, managing, and driving biological sample logistics across Phase I-IV Clinical Trials. This role is an essential member of the Clinical Operations function and must be able to collaborate with the cross-functional teams both internal and external. 

Responsibilities

• Support the Biosample Managers to deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
• Assist the Manager with overseeing sample collections, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
• Review clinical study protocols, informed consents, laboratory documents, case report forms, and laboratory scopes of work documents with guidance from sample managers.
• Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
• Contribute to the development and review of clinical site training materials and guidance documents.
• Support in developing reports on critical metrics around performance and sample chain of custody.
• Collaborate with cross-functional study teams to ensure delivery of samples per project milestones.
• Contribute to innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions.

Qualifications

• Bachelor’s degree, preferably in a scientific field.
• 6+ months Clinical trial experience in the pharmaceutical or health care sectors or equivalent academic setting.
• Understanding of ICH GCP and GLP guidelines.
• Prior laboratory or other sample handling experience preferred.
• Previous experience working within Biosample Operations would be a distinct advantage.
• Demonstrated ability to establish priorities, work with a strong sense of urgency and collaborate (interpersonal, relationship management) effectively with the study team, cross-functional team members and external partners/vendors.
• Self-motivated, assertive, and able to function both independently and as part of a team.
• Strong interpersonal and negotiation skills.
• Proficiency with Microsoft Office, advanced Microsoft Excel skills preferred.
• Effective verbal and written communication.
• Proven problem solving and decision-making skills.
• Ability and willingness to travel ~10%.

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