Job Details

  • Title: Clinical Biomarker Operation Manager
  • Code: RCI-07200
  • Location: Redwood City California (CA) 94063
  • Posted Date: 12/31/2019
  • Duration: 12 Months
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  Job Description

Description:

Clinical Biomarker Operation Manager
  • The Immuno-Oncology Clinical Biomarker group uses advanced methods to discover biomarkers and implement Translational Medicine strategies in early clinical studies to progress 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.
Key Responsibilities Include:
  • 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.
  • Prrovide 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 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, Standard Operating Procedures (SOPs).
  • Level and compensation will be commensurate with experience.
Basic Qualifications:
  • Bachelor’s Degree in a scientific discipline with 5+ years of related industry and/or academic work experience.
Preferred Qualifications:
  • Understanding of Translational Sciences and Companion Diagnostic development is a plus.
  • Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
  • Able to work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites.
  • 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.
  • 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.
  • Excellent communication and interpersonal skills, including problem solving, crisis management, change management, and conflict resolution. Proactive and positive team player.
  • Possesses strong oral and written communication skills; proven ability to successfully negotiate with and influence stakeholders with tact and diplomacy.
  • Proficient knowledge of all standard IT office tools; knowledge of LIMS systems a plus.
  • Project Management experience a plus.
Key Leadership Competencies:
  • Raises the bar and is never satisfied with the status quo.
  • Possesses strong interpersonal skills/emotional intelligence.
  • Ability to operate independently and learn quickly.
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Embraces the ideas of others and nurtures innovation.