Job Details

ID #19547202
State California
City Southsanfrancisco
Job type Contract
Salary USD Market Market
Source Software Management Consultants, Inc.
Showed 2021-09-13
Date 2021-09-10
Deadline 2021-11-08
Category Et cetera
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Project Manager - Clinical Biomarker/Diagnostics, Cinical/Biological Laboratory

California, Southsanfrancisco, 94080 Southsanfrancisco USA

Vacancy expired!

Job Description: SMCI is seeking a Clinical Biomarker and Diagnostics Operations Lead to plan and coordinate all project management and operational activities required to operationalize the company biomarker and diagnostics strategies. Ensure continuity and integrity across projects, coordinates assay development and implementation activities and acts as the primary point of contact for CBD operations for projects requiring biomarker and diagnostic activities including collection, delivery and analysis of biomarker and diagnostics biosamples within one or more clinical projects or clinical studies. Also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.

This position may be assigned to a client that requires all individuals on-site to have the COVID-19 vaccination. The individual must be fully vaccinated before starting work at such a client site.

Essential Duties and Job Functions:

  • Drives the implementation and execution of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas
  • Accountable for the development of a projects and/or clinical studys biomarker and diagnostics biosample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness
  • Accountable for project management and appropriate forecasting and planning of related biomarker analysis and samples management costs within a project(s) or clinical studies
  • Accountable for planning and implementing the biomarker and diagnostics biosamples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc
  • Accountable for ensuring that data received is consistent with collection and assay plan and protocols
  • Serves as first point of contact for biomarker and diagnostics biosamples operational questions and issues within a project(s) and coordinates with internal and external partners (e.g., Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads, and CROs)
  • Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s)
  • Provide regular reports on sample tracking to select samples for analysis based on varying criteria
  • Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans.
  • Participate in site initiation visits to train sites on sample collection
  • Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/ data results and is a key contact for the assay lab.
  • Project manages contracts, budgets and timelines for biomarker/Dx activities within studies to ensure timely completion of biomarker and diagnostic activities.

    Education/Qualifications
  • Life Sciences degree (higher qualification e.g. MSc or equivalent preferred).
  • Further qualification, e.g. project management certification is desirable.
  • Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
  • 5+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

    Experience, Skills, Knowledge
  • Extensive clinical development experience of working in teams running clinical studies
  • Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples
  • Project management skills and knowledge of project management tools
  • Critical reasoning skills including the identification and resolution of complex problems
  • Detail oriented with the ability to work independently and manage multiple competing priorities
  • Excellent planning, organizational and time management skills
  • Effective communication skillsRequired Skills: Clinical development and studies; Clinical/biological laboratory. Don't hesitate! Submit your resume today. SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm. (No third parties, please)(H1 sponsorship currently unavailable)(Local candidates only, please)

    Vacancy expired!

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