Biosample Operations Manager

South San Francisco, CA

Perm Salary

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OVERVIEW



We are currently searching for a skilled professional to join a well-known client’s team as a Bio-sample Operations Manager. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 


RESPONSIBILITIES

  • Accountable for planning, organizing and overseeing the collection and shipping of bio-samples from investigator sites or Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality
  • Partner with internal teams to understand and meet sample demand
  • Work with internal technical experts to ensure appropriate documentation/validations are in place and to define key sample criteria
  • Participate in the identification, selection and oversight of laboratory vendors including drafting RFPs and defining scope of work in support of study objectives and goals
  • Develop the strategy for a scalable sample storage, tracking and access
  • Support sample analysis, data transfer, data reconciliation, and data review
  • Provide study level updates to stakeholders, clinical study teams and biomarker teams including sample collection, assay status and analysis updates
  • Lead the development and finalization of the Biosample Management Plan (BMP) based on input from scientific and operational stakeholders to execute biomarker operational strategies

EXPERIENCE 

  • Five + years industry experience in drug development
  • Five + years clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Strong working knowledge of FDA & ICH/GCP regulations and guidelines
  • Effective team player and ability to collaborate with cross functional clinical study teams
  • Ability to manage lab vendors and oversee bio-sample management activities across multiple clinical trials
  • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
  • Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members
  • Strong organization, documentation and presentation skills across multiple priorities
  • Working knowledge of Microsoft Office Suite with emphasis on Excel skills

EDUCATION

  • BS/BA in Life Science or related discipline

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource  

About Advanced Clinical



Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.



Regarding your application



Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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