Specialist, Biosample Operations - Contractor

Summary The Specialist , Biosample Operations Contractor will   assist Biosample Manage rs 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.  R esponsibilities Support the Biosample Managers to deliver the sample strategy for clinical trial s within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP. Assist the M anager with oversee ing 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. Q ualifications 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 B iosample O perations 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 , a dvanced Microsoft Excel skills preferred . Effective   verbal and written communication . Proven problem solving and   decision-making   skills . Ability and willingness to travel ~10% . #LI-JS1 #LI-Remote