Clinical Operations Manager

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 1994 we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies 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 2017 we passed a FDA inspection and were recommended to be approved for commercial drug substance 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.

• Bachelors 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.

• Medical dental and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employees 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 ($20000 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

Required Experience:

Manager