From CSBio's posting. “We” and “our” refer to the employer.
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 escalate 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
About this listing
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
