Clinical Operations Leader – Longevity & Oncology

CSBio; Milpitas (CA); On-site; USD 140,000 - 195,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k 10% match

PTO 10 days

Company holidays

Life insurance

Disability insurance

Carpool reimbursement

Employee rewards program

Social events

Team building activities

Job summary

CSBio in Milpitas, CA, seeks a hands-on Clinical Operations Manager to lead planning and execution of longevity and oncology clinical programs. Reporting to the Chief Medical Officer, you will translate clinical strategy into operating plans, lead study start-up, coordinate sites and vendors, manage timelines and budgets, and ensure compliant execution from feasibility to closeout.

The role requires a life sciences degree, 5+ years in clinical operations, experience with start-up, monitoring,

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, public health, clinical research or a related field.
• 5+ years of progressive clinical operations experience in biotech, pharma, CRO, or clinical-site settings.
• 2+ years of experience leading clinical studies, sites, vendors or operations personnel.
• Experience with study start-up, site initiation and activation, monitoring and enrollment.
• Knowledge of ICH-GCP, informed consent, essential documents and inspection readiness.
• Experience managing timelines, budgets, contracts and CRO/vendor relationships.
• Strong written communication, meeting leadership, documentation and problem solving.
• Ability to work on-site and travel to clinical sites and vendors.

Responsibilities

• Lead clinical operations across longevity and oncology studies from feasibility through closeout.
• Translate protocols into actionable operating plans, timelines, and site workflows.
• Lead site identification, feasibility, qualification, selection, budget coordination and activation.
• Coordinate investigators, clinical sites, CROs, labs, pharmacies, imaging and other partners.
• Own start-up tracking, regulatory submissions, contracts, budgets and training.
• Develop and manage clinical operations budgets, forecasts and change orders.
• Establish enrollment, monitoring, data, and milestone tracking for each study.
• Oversee participant recruitment, site performance, and data-quality activities.
• Plan monitoring activities with internal staff or CROs, with escalation and closure of actions.
• Ensure Trial Master File and site files are inspection-ready in collaboration with QA and Regulatory.
• Identify and escalate operational, safety, medical, regulatory and timeline risks.
• Lead cross-functional study meetings and report status to CMO and leadership.
• Create SOPs, templates and training; supervise clinical operations personnel.

Skills

Communication skills

Leadership

Problem-solving

Documentation

Time management

Travel readiness

Education

Bachelor's degree in life sciences or related field

Job description

CSBio in Milpitas, CA, seeks a hands-on Clinical Operations Manager to lead planning and execution of longevity and oncology clinical programs. Reporting to the Chief Medical Officer, you will translate clinical strategy into operating plans, lead study start-up, coordinate sites and vendors, manage timelines and budgets, and ensure compliant execution from feasibility to closeout.

The role requires a life sciences degree, 5+ years in clinical operations, experience with start-up, monitoring,