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Clinical Biomarker and Diagnostics Operations Lead – REMOTE -(JP10211)

South San Francisco, CA · Biotech/Pharmaceutical
Job Title:  Clinical Biomarker and Diagnostics Operations Lead – REMOTE -(JP10211)
Location: South San Francisco, CA. 94080 (100% REMOTE)
Employment Type:  Contract
Business Unit: Clinical Biomarkers CINC
Duration: 1+ years (with likely extensions)
Notes:  Role will be supporting general medicine therapeutic areas. Experience in general medicine preferred (Inflammation, Cardio Metabolic, Neuroscience). Candidate can be located in South San Francisco or Thousand Oaks office or be fully remote. 
Posting Date:  05/04/2022

3 Key Consulting is hiring a Clinical Biomarker and Diagnostics Operations Lead for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the client biomarker and diagnostics strategies for programs in the Inflammation and Cardio Metabolic therapeutic areas of client (General Medicine). He/she ensures 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. He/she is also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.  Essential duties and job requirements include:
 
  • 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 project’s and/or clinical study’s 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.

Basic 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)
  • 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
  • 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 skills

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:
  • Experience with planning and implementing the biomarker and diagnostics biosamples collection plans within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up.
  • Project management experience in the implementation of clinical trial assays at reference labs and centralized testing vendors, ensuring delivery of assay/ data results and being a key contact for the assay lab; project management skills and knowledge of project management tools is required.
  • Experience working with major CROs, providing vendor oversight.

Day to Day Responsibilities:
  • The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the clientbiomarker and diagnostics strategies for programs in the Inflammation and Cardio Metabolic therapeutic areas of client (General Medicine).
  • He/she ensures 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.
  • He/she is also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.

Employee Value Proposition:
  • Exposure to leadership & cross functional departments
  • Opportunity to be part of delivering personalized client medicine
  • Integrating multiple work streams

Red Flags:
  • Lack of organizational skills and attention to detail, lack of must have skills, not having any biomarker and biosample operational management experience.
  • Resume is too heavy on academical laboratory experience and shows absence of clinical trials experience; lack of industry experience.

Interview process:
Phone screening followed by in-person interview.



We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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