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Project Manager III (BioAnalytical)

Job Description

Project Manager III (BioAnalytical)
South San Francisco, CA

Duties:

BioAnalytical Sciences (Client) develops implements and provides strategic direction for state of the art bioanalytical methods and automation systems. Client 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, duties include: 
  • works with clinical study teams, contracting group, data group, DMPK, Client, central labs and contract labs to outsource and manage biosample (PK/ATA) analysis.
  • simultaneously assigned to multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study.
Main responsibilities 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 pre-clinical researched 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
Skills:
  • Bachelor's degree or Master's degree in a scientific discipline
  • 5 + years of experience in related field that includes experience working in the biotech industry
  • Experience working with clinical study teams involved in the processing and/or analysis of biological samples
  • Technical experience/knowledge of bioanalytical assay methods.
The Extra Fluff: 
  • 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.

Job Requirements

 

Job Snapshot

Location US-CA-South San Francisco
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-South San Francisco
Rohit Bohra
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Snapshot
Ascent
Company:
US-CA-South San Francisco
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific
Store Type:

Job Description

Project Manager III (BioAnalytical)
South San Francisco, CA

Duties:

BioAnalytical Sciences (Client) develops implements and provides strategic direction for state of the art bioanalytical methods and automation systems. Client 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, duties include: 
  • works with clinical study teams, contracting group, data group, DMPK, Client, central labs and contract labs to outsource and manage biosample (PK/ATA) analysis.
  • simultaneously assigned to multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study.
Main responsibilities 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 pre-clinical researched 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
Skills:
  • Bachelor's degree or Master's degree in a scientific discipline
  • 5 + years of experience in related field that includes experience working in the biotech industry
  • Experience working with clinical study teams involved in the processing and/or analysis of biological samples
  • Technical experience/knowledge of bioanalytical assay methods.
The Extra Fluff: 
  • 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.

Job Requirements

 
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