Job Title: Mgr Clinical Biomarkers & Diagnostics Duration: 1 Year Location: Fully remote (standard business hours aligned to CA)
Description: *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 *Please submit candidate at market rate for review *During candidates screening please ask candidates to submit the written examples of emails, agenda, meetings minutes, timelines to demonstrate written communication and project management skills (do not ask to submit confidential information, ask to submit neutral examples)
Specific Job Requirements: The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the company’s biomarker and diagnostics strategies for programs in the Inflammation and Cardio Metabolic therapeutic areas of company’s (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 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 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.
Preferred 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) • 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
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
Basic Qualifications: Doctorate degree OR Master’s degree and 3 years of experience OR Bachelor’s degree and 5 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
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 or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Top 3 Must Have Skill Sets: Biomarker Operations experience managing Biomarker samples, biomarker vendors and central labs. Project management experience and knowledge of project management tools, experience with software building timelines, experience organizing meetings, recording agenda and minutes. Extensive clinical development experience of working in teams running clinical studies, must be able to contribute to protocols and ICFs development. This is NOT a clinical trail manager role or clinical science role *** a background of this is OKAY but they MUST be able to speak to why their looking to move into this area (it is a biomarkers role who does work closely with clinical team)
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 company’s biomarker and diagnostics strategies for programs in the Inflammation and Cardio Metabolic therapeutic areas of company’s (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 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 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.
Possible Extension: Yes Red Flags: No clinical trial management experience. No industry experience - anything under 4 years. Unexplained gaps in work history. Lack of biomarker operations experience and understanding of biomarker samples lifecycle management. Poor communication and emails writing technique. Lack of project management experience, including building timeline, agenda and minutes
Interview Process: Phone screen by hiring manager with follow up individual interviews with team members. 1 or 2 rounds of interviews.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $60.00/hr.
