Clinical Operations Manager

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 is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

We seeking a hands-on Clinical Operations Manager to lead the planning and execution of longevity and oncology clinical programs. Reporting to the Chief Medical Officer, this person will translate clinical strategy and protocols into practical operating plans, lead study and site start-up, coordinate sites and vendors, manage timelines and budgets, and ensure consistent execution from feasibility through closeout. The Manager will support the build while preserving the medical, safety, regulatory, and investigator authority of qualified owners.

Job Duties

• Lead clinical operations across longevity and oncology studies from feasibility and planning through study start-up, enrollment, conduct, closeout, and archival
• Translate protocols into detailed operating plans, study timelines, responsibility matrices, site workflows, visit requirements, staffing plans, vendor plans, and readiness criteria
• Lead site identification, feasibility, qualification, selection, budget and contract coordination, initiation, activation, ongoing management, and closeout
• Coordinate investigators, clinical sites, CROs, central and specialty laboratories, pharmacies, imaging providers, couriers, technology vendors, and other study partners
• Own study start-up and site-activation tracking, including essential documents, regulatory and ethics submissions, contracts, budgets, training, supplies, systems access, delegation, and activation dependencies
• Develop and manage clinical operations budgets, forecasts, purchase requests, vendor scopes, invoices, and change orders within approved company controls
• Establish enrollment, visit, monitoring, data, specimen, investigational-product, issue, risk, and milestone tracking appropriate to each study
• Oversee participant-recruitment readiness, site performance, enrollment progress, protocol adherence, data-cleaning support, query resolution, and corrective action follow-through
• Plan and oversee monitoring activities using internal personnel or CROs, including monitoring plans, visit reports, findings, escalation, and closure of action items
• Ensure the Trial Master File and site files are complete, current, controlled, and inspection ready in coordination with Regulatory, Quality, and study-site personnel
• Identify and escalation operational, safety, medical, regulatory, quality, supply, and timeline risks to the appropriate qualified owner; maintain clear decision and action logs
• Lead cross-functional study meetings and provide concise status reporting to the CMO and leadership on milestones, enrollment, budget, risks, decisions, and recovery plans
• Create and maintain fit-for-purpose clinical operations SOPs, work instructions, templates, training, metrics, and vendor oversight practices with Quality and Regulatory review as applicable
• Hire, train, supervise, and develop clinical operations personnel, including clinical research coordinators and study-management staff; establish clear responsibilities and backup coverage
• Support audits, inspections, due diligence, and sponsor or partner reviews by providing complete operational records and timely responses

Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, public health, clinical research, or a related field; equivalent relevant experience may be considered
• 5+ years of progressive clinical operations experience in biotechnology, pharmaceuticals, a CRO, an academic research center, or a clinical-site organization
• 2+ years of experience leading clinical studies, sites, vendors, projects, or clinical operations personnel
• Demonstrated experience with study start-up, site initiation and activation, study conduct, monitoring oversight, enrollment, vendor coordination, and closeout
• Working knowledge of ICH-GCP, informed-consent requirements, protocol compliance, essential documents, safety escalation, privacy, and inspection readiness
• Experience managing clinical timelines, budgets, contracts, CROs or vendors, risks, and cross-functional dependencies
• Strong written communication, meeting leadership, documentation, prioritization, and practical problem-solving skills
• Ability to work on site as required and travel to clinical sites, investigators, and vendors

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental)
• Disability insurance 50% standard employer paid
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities