Clinical Operations Lead
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AI Summary
The Clinical Operations Lead oversees the planning, management, and execution of clinical studies and collaboration programs. This role includes providing strategic and hands-on operational leadership across various aspects of clinical operations.
CLINICAL OPERATIONS LEAD
ABOUT US:
Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.
Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.
Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics.
For more information, please visit www.biodesix.com
THE ROLE:
Note: Final job title and level will be determined based on experience. The Clinical Operations Lead oversees the planning, management, and execution of clinical studies and collaboration programs. This role provides strategic and hands‑on operational leadership across protocol development, site selection, monitoring oversight, IRB submissions, patient recruitment strategies, and study material coordination.
The Clinical Operations Lead partners closely with the VP of Clinical Research and cross-functional teams—including Regulatory Affairs and Laboratory Operations—to ensure all studies are delivered on time, within budget, and in alignment with quality and compliance standards. The role is also responsible for leading the clinical operations team and developing operational frameworks, efficiencies, and best practices.
WHAT YOU'LL DO:
STUDY OPERATIONS & LEADERSHIP
- Serve as the primary owner of timelines, deliverables, quality, and trial performance.
- Develop and manage study plans, timelines, milestones, and performance metrics.
- Identify risks, lead proactive mitigation strategies and implement corrective actions.
- Lead cross‑functional study teams (clinical, data management, regulatory, lab, vendors, etc.).
- Present status, risk, and resource needs to senior leadership.
- Develop study-specific materials including protocols, monitoring plans, study tools, and CRF guidelines.
CRA TEAM LEADERSHIP
- Manage, train, mentor, and support CRAs, including onboarding and performance oversight.
- Provide ongoing training on protocol requirements, GCP, SOPs, and monitoring expectations.
- Review monitoring reports and follow-up letters; ensure timely issue resolution and quality oversight.
- Promote best practices for site management and monitoring.
SITE & VENDOR MANAGEMENT
- Oversee all phases of site management (qualification → closeout).
- Review site performance metrics (enrollment, data quality, deviations) and implement SOPs
- Lead site budget and contract negotiations.
- Participate in vendor selection and manage vendor performance and deliverables.
- Manage and track study supplies and materials.
DOCUMENTATION & COMPLIANCE
- Maintain audit‑ready clinical documentation and ensure compliance with FDA, ICH-GCP, SOPs and applicable regulations.
- Manage and track regulatory/IRB/IEC submissions and approvals.
- Support and follow up on quality assurance audits.
- Contribute to protocols, study tools, monitoring plans, and CRF guidelines.
COMMUNICATION & MEETINGS
- Lead study meetings (investigator meetings, CRA/CRO meetings, team meetings).
- Coordinate meeting logistics, prepare materials, and document minutes
- Develop and distribute study communications such as newsletters and site updates.
ADDITIONAL TASKS
- Support and conduct site visits, prepare monitoring reports.
WHAT YOU'LL BRING:
- Advanced project and clinical trial management skills
- In-depth knowledge of ICH/GCP guidelines and FDA regulations.
- Ability to work independently
- Excellent oral and written communication skills
- Experience as manager with direct reports
- Ability to travel intermittently (total travel up to 25%)
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B.S. in a scientific or healthcare related field
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At least 4 years Clinical Study experience and 3-5 years of managing professional staff
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CCRA, ACRP-CP or ACRP-PM certification preferred
WHAT YOU'LL GET:
- Competitive base salary: $127,000 - $150,000
- Discretionary bonus opportunity
- Comprehensive health coverage: Medical, Dental, and Vision
- Insurance: Short/Long Term Disability and Life Insurance
- Financial benefits: 401(k), Flex Spending Account
- 120 hours annual vacation
- 72 hours paid sick time
- 11 paid holidays + 3 floating holidays
- Employee Assistance Program
- Voluntary Benefits
- Employee recognition program
Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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