Clinical Biomarker Operation Manager

  • location: Redwood City, CA
  • type: Contract
  • salary: $50 - $54.12 per hour
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job description

Clinical Biomarker Operation Manager

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

location: Redwood City, California
job type: Contract
salary: $50.00 - 54.12 per hour
work hours: 9 to 5
education: Bachelors
  • The Immuno-Oncology Clinical Biomarker group at Company uses advanced methods to discover biomarkers and implement Translational Medicine strategies in early clinical studies to progress Company's innovative Oncology pipeline. We are currently seeking a highly motivated individual to join our Biomarker Operations team to support the implementation of Clinical Biomarker strategies. As a member of project teams, he/she will have the opportunity to work in a highly collaborative environment to support projects across Oncology Early Development with a focus on Immuno-Oncology.
  • Provide hands-on support to enable biomarker assay implementation in clinical trials, including sample and data management, and CRO management.
  • Review Clinical Biomarker sections in key clinical documents including Protocols, Informed Consent Forms, Contracts, and Clinical Study Reports. Provide input into trial-specific agreements and statements of work with vendors.
  • Provide operation support to Biomarker Leads to ensure the delivery of bio-sample data in accordance with study timelines
  • Maintain open and frequent communication with various Company functions such as Clinical Operations. Maintain a positive working relationship with internal/external customers. May assist CRA in training sites on sample collection/handling.
  • Adhere to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, Company Standard Operating Procedures (SOPs).
  • Bachelor's Degree in a scientific discipline with 5+ years of related industry and/or academic work experience.
Preferred Qualifications:

  • Proficient in the conduct of clinical trials and associated activities and responsibilities, as well as experience interacting with clinical trial teams; strong background in oncology a plus.
  • Previous experience with Clinical Biomarker Operations.
  • Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with multiple high priority competing projects and deadlines.
  • Excellent communication and interpersonal skills, including problem solving, crisis management, change management, and conflict resolution. Proactive and positive team player.
  • Able to work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites.
  • Possesses strong oral and written communication skills; proven ability to successfully negotiate with and influence stakeholders with tact and diplomacy.
  • Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
  • Proficient knowledge of all standard IT office tools; knowledge of LIMS systems a plus.
  • Understanding of Translational Sciences and Companion Diagnostic development is a plus.
  • Project Management experience a plus.
Key Leadership Competencies:

  • Ability to operate independently and learn quickly.
  • Possesses strong interpersonal skills/emotional intelligence.
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Raises the bar and is never satisfied with the status quo.
  • Embraces the ideas of others and nurtures innovation.
skills: FDA, GCP (Good Clinical Practice), ICH Regulations, LIMS (Laboratory Information Management System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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