Clinical Biosample Operations Associate/Manager

REPORTS TO (POSITION): Senior Clinical Biosample Operations Manager

LOCATION: San Francisco Bay Area, CA

DEPARTMENT NAME: Translational Science

HR DESIGNATIONS: PAY STATUS – EXEMPT

Objective of Position

  • The Clinical Biosample Operations Associate / Manager oversees activities of collection, delivery and assay of biosamples including Biomarkers, PK and PD within clinical studies
  • The Clinical Biosample Operations Associate / Manager delegates tasks, establishes workflows and timelines for analytical needs to support corporate goals
  • To ensure biosample process consistency across all clinical studies within their respective projects and manages sample logistics from patient to data.    
  • Collaborates with Translational Science Strategist and stakeholders of all levels to ensure sample management consistency and appropriate delivery and completion of tasks

Essential Duties/ Responsibilities

  • Initiate contracts and budget negotiations with vendors, manage and track tasks, facilitate discussions with stakeholders, and push through with deliverables to ensure finalization is within appropriate timelines
  • Liaises with translational and pharmacokinetic scientists and clinical teams to establish analysis needs with clinical feasibility   
  • Collaborates with business partners and stakeholders on demands and expectations for all functions involved in the project
  • Establish productive working relationships with sites, vendors, business partners, and other stakeholders
  • Serve as an active member of the Clinical Study Team to obtain and provide updates on the progress of the trial in regards to sample management
  • Must be able to identify and mitigate risks to ensure accuracy in sample collection, delivery, and analysis
  • Keep track of follow up items for sample activities within clinical studies
  • Draft and review laboratory manuals to ensure accuracy and consistency with the study protocol and clinical needs
  • Manage Acerta Lab in PD sample logistics which involve sample delivery, query resolutions, negotiating with couriers and external vendors to streamline sample collection and shipment
  • Facilitate sample shipments and query resolutions among vendors to ensure timely data delivery as needed
  • Manage Acerta Pharma biobank
  • Identify issues and be proactive in urgently escalating and resolving them
  • Track and manage all sample related activities or PK, PD, and Biomarkers routinely and provide updates when appropriate
  • Have a strong understanding of scientific needs as well as clinical processes to bridge the needs between these functions
  • Understand and assist in data reporting needs for each clinical study

Requirements

  • Excellent communication skills and ability to consistently keep track of all tasks
  • Maintain professional demeanor under stressful situations
  • Must be very diligent and extremely organized
  • Proven record of successfully managing multiple competing priorities
  • Self-motivated and a quick learner who’s able to take on tasks with minimal direction
  • Must have a strong research and clinical background

Education/ Training

  • Life sciences degree and a minimum of 6 years working experience in the biotech/pharma industry
  • Proven clinical development experience working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Proven critical reasoning skills including the identification and resolution of complex problems
  • Proficient in Microsoft Office Applications including Excel, Word, and PowerPoint


Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. 

Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.