Sourcing Manager
SeraCare - Frederick, MD

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Reporting to the VP of Bioservices, this position effectively manages the direction and strategy for sourcing biological samples from healthy and disease state donors. This includes samples that are available through prospective, observational clinical studies. The successful candidate will manage and develop clinical study collection sites in accordance with applicable local, federal and international regulations, and within the defined budget. Recruiting potential new clinical study collection sites, establishing appropriate protocols and informed consents is a critical component of this position.

In addition, processing and reviewing essential documents according to project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP Guidelines and good documentation practices is key. This role manages all aspects of IRB processes including communication, document filing and file maintenance.

This position will actively participate in multiple internal cross-functional teams to ensure the effective delivery of all functional and departmental milestones. We are seeking a candidate that is highly motivated, with a strong ability to work independently.

QUALIFICATIONS:

A Bachelors’ degree in a scientific discipline or registered nurse (4 year degree) or equivalent work experience is required. Master’s degree preferred. A minimum of 3 years of clinical trial experience within a pharmaceutical and/or healthcare setting and 1 year of clinical trial site management experience, including site monitoring is required. Demonstrated analytical, negotiation, meeting management, cross-functional team and leadership skills at a management level is required. Knowledge of applicable human subjects research regulations is preferred. 30% - 40% travel is required. Demonstrated computer skills (MS Office, MS Project, and PowerPoint) are essential. Must be able to read, write, speak fluently and comprehend the English language.

SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V

SeraCare - 18 months ago - save job - block
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