Software Guidance & Assistance, Inc., (SGA), is searching for a Biomarker Clinical Operations Lead for a contract assignment with one of our premier Pharmaceutical services clients in South San Francisco, CA.
Responsibilities :
The Biomarker Clinical Operations Lead (Biomarker Operations Project Manager accountable) in PDG at the firm is responsible and accountable to provide BIOMARKER OPERATIONAL EXPERTISE by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for PDG clinical studies.
As Biomarker Clinical Operations Lead, your responsibilities will include as directed:
Provide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data delivery
Be accountable for the development of the BIOMARKER MANAGEMENT PLAN and the execution of deliverables for assigned drug and device studies (e.g. IVD clinical performance studies) in partnership with the Clinical Study Lead or designee
Manage all study level biomarker operations activities for both clinical (i.e. drug) and IVD studies (e.g. manage vendor/testing sites, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality and transfer set-up)
Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, shipping conditions and logistics for biomarker samples
Lead identification, selection and oversight of BIOMARKER VENDORS, including development and oversight of scope of work, budget, ensuring quality delivery and performance
Actively partner with Data Management to oversee and coordinate biomarker data format and delivery timelines
COLLABORATE AND PARTNER with cross functional stakeholders (e.g. study team members, biomarker science, CDx, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker/IVD operational strategies, serving as a single point of contact for biomarker/IVD operations on multiple study teams
Provide technical knowledge of aspects related to biomarker analyses (e.g. sample collection and handling, assay, device and imaging technologies)
Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring adherence to ICH/GCP, SOPs, ISO 20916 and regulatory requirements
Attend operations team meetings and investigator/monitor meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection, handling and IVD procedures
Provide responses to biomarker sample/IVD related questions or issues from Health Authorities
IDENTIFY AREAS OF BEST PRACTICE and process improvements and contribute to/lead initiatives (if requested)
You will work on business priorities as directed
Expectation of ongoing and sustained onsite presence in compliance with local requirements
Required Skills:
Minimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area).
3+ years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Extensive clinical development experience with evidence of working in teams running clinical studies
Strong experience with vendor and project management
Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines
Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
Experience working in a global and matrix environment
Excellent collaboration, communication, influencing and presentation skills
Critical reasoning skills including the identification and resolution of complex problems
Detail oriented with the ability to work independently and manage multiple competing priorities
Preferred Skills:
Further qualification, e.g. PhD and/or project management certification is desirable.
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.