workable
Clinical Operations Manager
CSBio
Milpitas, USA
Full-time
Senior · 5+ years experience
Onsite
Discovered 3 weeks ago
Full Job Posting
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 CSBio
Pharmaceutical Manufacturing99 employeesFounded 1993
Private peptide manufacturer making automated synthesizers and custom and cGMP peptides for biotech, academic, and pharmaceutical customers.
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