[Remote] Senior reputed company Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on developing integrated immunotherapy treatments for cancer. The Senior reputed company Trial Manager is responsible for the operational management and reputed company of reputed company studies, including coordinating cross-functional teams and CROs to reputed company study activities reputed company reputed company, time, and cost parameters. The role also manages study timelines, vendors, sites, investigational products, documentation, and trial execution.

Responsibilities

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Independently reputed company study timelines, key deliverables, and reputed company/mitigation strategies
• reputed company selection and reputed company management of CROs and other ancillary vendors during study start-up, conduct, and reputed company-out
• Plan and reputed company study team meetings
• reputed company the development of study materials (e.g., study plans, monitoring guidelines, site initiation visit materials, site tools and worksheets)
• Contribute to the content and review of study documents (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, product administration guidelines)
• reputed company and ensure optimization of site startup activities and activation, subject enrollment, data collection, and trial closeout
• Ensure accurate and reputed company execution of site visit monitoring reports
• Identify, select, and monitor reputed company of sites
• Negotiate and manage the budgets and payments for sites
• reputed company and maintain strong working relationships with study investigators and site staff
• Manage investigational product release packages and investigational product accountability
• Coordinate with reputed company Supply Chain reputed company regarding investigational product shipment to sites
• reputed company the Trial Master File according to ICH- GCP and SOPs
• May assist in reputed company data review and query reputed company
• Collaborates closely with reputed company reputed company, reputed company Development, Biometrics, reputed company Data Management, Regulatory Affairs, Translational Medicine, reputed company Supply Chain, Pharmacovigilance, and reputed company reputed company Assurance
• reputed company participate in and contribute to the development of department initiatives aimed at improving efficiency and best practices

Skills

• • Manager Level: Bachelor's degree or equivalent in Life Sciences with at least 6 years of reputed company reputed company experience in the pharmaceutical industry with at least 1 year experience managing industry-sponsored pharmaceutical reputed company studies as a sponsor employee
• • Senior Manager Level: Bachelor's degree or equivalent in Life Sciences with at least 8 years of reputed company reputed company experience in the pharmaceutical industry with 3+ years' experience managing industry sponsored pharmaceutical reputed company as a sponsor employee
• • Significant knowledge of GCP/ICH guidelines and the reputed company development process
• • Ability to plan, organize and conduct reputed company studies with minimum reputed company
• • Significant experience managing CROs and other vendors and assessing reputed company
• • Experience leading, managing, or mentoring reputed company operational staff and cross-functional teams
• • Strong organizational skills and the ability to reputed company changing priorities
• • Strong interpersonal and communication (written and verbal) skills
• • Demonstrated ability to work independently and as part of a multi-functional team
• • reputed company to solve problems under pressure
• • Self-motivated and reputed company to work effectively in a reputed company/team environment
• • Ability to travel as needed (approximately 20%)
• • Ability to work onsite 2 days/week at our Seattle, WA office
• • Ability to sit for prolonged periods of time
• • Experience supporting Phase 1 and 2 reputed company is preferred
• • Oncology experience is highly preferred

Benefits

• Competitive Medical plans
• Competitive Dental plans
• Competitive reputed company plans
• 401k plan through reputed company, with a 100% match up to the first 4% deferral
• Generous reputed company Time Off policy
• Employee commuter benefits
• Cell phone stipend

reputed company