Position Type: Regular

Position Title: Senior/BioSpecimen Acquisition Manager

Location: San Francisco East Bay, CA

Position Number: 715 and 716 (senior position)

Required - Clinical Project Manager or biospecimen scientist with vendor management, scientific knowledge, procurement of clinical trial biospecimen pathogen-borne samples and technical writing ability. Must be proactive, creative and highly resourceful.

Key responsibilities include management of the design, planning, and implementation of the collection of human clinical biospecimen samples for a global biopharmaceutical company based in the San Francisco East Bay. 

Work in an environment; where performance is recognized and career progression is supported; where open communications that allows for differing and challenging opinions are encouraged and where a strong work-life balance is a reality. 

Relocation support and a competitive compensation package are offered

Role:

• Design, write and review sample collection study protocols, negotiate collection study contracts, and facilitate purchase requisitions.
• Coordinate the activities of relevant colleagues and external suppliers to monitor compliance with the sample collection study protocols and quality standards, including, but not limited to, the collection and maintenance of legal and regulatory documentation, ethics committee approvals, accurate and complete data collection, import/export permits, managing material logistics, and management of collection study information in a sample management system.
• Maintain a high level of professional expertise through familiarity with regulations, scientific literature, product portfolio and competitive environment.
• Develop and maintain a supplier database. Travel to supplier sites to audit quality standards, monitor sample collection studies, and identify and resolve discrepancies associated with sample collection projects
• Participate in Project Team Meetings and provides periodic updates on sample collection projects.
• Mentor and provide guidance to junior associates.
• Organized and detail-oriented individual with writing, analytical, technical and interpersonal skills to work with sample sources such as, international investigators and key customers in the medical community.

Requirements:

• BS/MS in biological discipline or related field or equivalent combination of education and work-related experience.
• In addition to substantive experience, at least 3 years of experience in a significant management role, and an in-depth understanding of clinical trial procedures, GCP and FDA regulations relative to specimen collections.

Salary Range: 100K+

Contact: Apogee Clinical