Project Manager Job

PROJECT MANAGER needed for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Technical experience/knowledge of bioanalytical assay methods
- Bachelor's degree or Master's degree

WHAT YOU'LL BE DOING:

- BioAnalytical Sciences (BAS) develops implements and provides strategic direction for state of the art bioanalytical methods and automation systems.
- BAS data and expertise enable the characterization of the pharmacokinetic, immunogenic and in vitro biological activities of biotherapeutics during drug development and throughout the product life cycle.
- The BioAnalytical Manager (BAM) is a project management role in BAS.
- BAM works with clinical study teams, contracting group, data group, DMPK, BAS, central labs and contract labs to outsource and manage biosample (PK/ATA) analysis.
- The BAM is simultaneously assigned to multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study.
- The responsibilities for BioAnalytical Manager include: Driving the development of assay vendor SOWs, managing vendor contracts, including review of invoices, ensuring receipt of SOW deliverables, resolving or escalating issues where needed, and closing contracts
- Assist with identifying and on-boarding assay vendors including SOW development, budget planning, and specifying data formats
- Preparing vendor oversight plans for each study as needed.
- Ensuring alignment with cross-functional stakeholders and document team decisions in the PK/ATA Sample Flow Diagram
- Developing timelines for PK and ATA data for managing contract labs to ensure samples are tested according to protocol/team timelines, data is returned in the specified format, and all SOW specified deliverables are met
- Overseeing shipping and receipt of biosamples from central labs to assay laboratories
- Providing biosample metrics and status updates to teams as requested
- Supporting clinical study teams (PET/SMT), pharmacology teams through attending appropriate meetings as needed
- Serving as the on-going operational point of contact between internal gRED functions and assay vendors for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and data reportable tracking
- Making arrangement for samples and data handling/archiving at the completion of the study

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree or Master's degree in a scientific discipline
- Five (5+) years of experience in related field that includes experience working in the biotech industry and in clinical study teams with involvement in the processing and/or analysis of biological samples
- Ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams
- Ability to work in a highly matrixed organization in a positive and collaborative manner
- Strong organizational skills with attention to details
- Independently manage multiple competing priorities, while working on multiple projects simultaneously
- Excellent communication and presentation skills and effective influencing/negotiating skills.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Bachelor's degree or Master's degree in a scientific discipline

RECRUITER:Mary Nguyen

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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