Mgr Clinical Biomarkers & Diagnostics- West Coast PST

TEKsystems
$65.00 - $92.00 / hr
life insurance, sick time, 401(k), retirement plan
United States, California, Thousand Oaks
Mar 13, 2025
Workplace Type: 100% Remote Worksite Location: 1 Amgen Center Drive, Thousand Oaks, California, 91320, United States Job Title: Mgr Clinical Biomarkers & Diagnostics Job Category: Project Manager (General) Job Titles Used for Match: Biomarker Operations Manager, Biosample Operations Manager Top Skills - Must Haves: * Biomarker operations * Biospecimen management * Project management Top Skills' Details: Preferred previous titles: Biomarker Operations Manager, Biosample Operations Manager, or Biospecimen Operations Manager. Not looking for clinical trials managers or clinical researchers. This is an operational-focused project management role. Experience in general medicine preferred (Inflammation, Cardio Metabolic, Rare Disease). Must Have Experience, Skills, Knowledge: Extensive 2+ years Biomarker Operations experience * Experience with biospecimens management, must know the different types of biomarker samples and specifications for collection and lifecycle * Extensive clinical development experience of working in teams running clinical studies, must be able to contribute to protocols and ICFs development * Extensive Project management skills and knowledge of project management tools is a must, prepare to demonstrate during interview * 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 In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above. Education Required: * 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. Secondary Skills - Nice to Haves: Job Description: Role will be supporting general medicine therapeutic areas. Specific Job Requirements: The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the biomarker and diagnostics strategies for programs in the Rare Disease, Inflammation, Cardio Metabolic therapeutic areas. 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 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 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 the 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). * Provides 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. * Participates 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. Pay and Benefits The pay range for this position is $65.00 - $92.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Mar 24, 2025. About TEKsystems: We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.