Company:  Confidential

Job Title: Specialist, Biosample Operations, Contractor

Job Number: 87231

Location: Remote, US

Job Description

The Specialist, Biosample Operations will support Biosample Managers in the planning, implementation, management, and coordination of biological sample logistics. This role is crucial to the Clinical Operations team and requires effective collaboration with both internal and external cross-functional teams. This position offers remote work flexibility or the option for in-house/hybrid arrangements for candidates located in the Bay Area. Includes approximately 10% travel, both domestic and international.

Responsibilities

* Assist Biosample Managers in executing the sample strategy for clinical trials, ensuring compliance with quality, ethical, and regulatory standards. * Support the Manager in overseeing the collection, processing, storage, and reconciliation of samples. * Review informed consent forms to ensure the sample language aligns with the study’s objectives and analysis plans. * Collaborate with sample managers to review clinical study protocols, laboratory documents, case report forms, and laboratory scopes of work. * Organize and file relevant vendor laboratory documents for the Trial Master File (TMF) as necessary. * Assist in developing and reviewing training materials and guidance documents for clinical sites. * Help prepare reports on key performance metrics related to sample management and chain of custody. * Work with cross-functional study teams to ensure timely delivery of samples in accordance with project milestones. * Contribute to innovation and process improvement initiatives within Biosample Operations and the broader Clinical Operations functions.

Required Skills

QUALIFICATIONS: * Bachelor’s degree in a scientific discipline is preferred. * 0-2 years of experience in clinical trials within the pharmaceutical or healthcare sectors, or in a comparable academic environment. * Familiarity with reviewing informed consent forms (ICFs).SKILLS/ABILITIES: * Solid understanding of ICH, GCP, and GLP guidelines. * Prior experience in laboratory settings or sample handling is preferred. * Previous experience in Biosample Operations. * Proven ability to prioritize tasks, work with a sense of urgency, and collaborate effectively. * Self-motivated and assertive, capable of working independently as well as part of a team. * Strong interpersonal and negotiation skills. * Proficient in Microsoft Office, with advanced skills in Excel preferred. * Effective verbal and written communication abilities. * Strong problem-solving and decision-making skills. * Willingness and ability to travel approximately 10%.

Application Deadline: 2024-12-02

 

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