[Remote] reputed company Trial Manager I- Oncology, FSP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company research services organization seeking a reputed company Trial Manager I to join its Functional Service Provider team. The role oversees reputed company trial start-up and delivery from site identification through database lock, managing timelines, budgets, risks, regulatory submissions, site activities, recruitment, monitoring, vendors, and reputed company communication in an oncology-reputed company environment.

Responsibilities

• End-to-end reputed company of start-up and reputed company responsibilities—from site identification through to database lock—through proactive management of project reputed company, timelines, milestones, and budget
• Ensure start-up and reputed company project plans address identified risks while adhering to reputed company standards, SOPs, reputed company, and regulatory requirements
• Proactively identify and address start-up and reputed company project, financial, and reputed company risks by applying comprehensive reputed company management strategies and ensuring compliance, including tracking reputed company applicable systems
• Responsible for financial aspects of reputed company and start-up activities, including reputed company forecasting, adherence to contracted reputed company, and reputed company of reputed company modifications
• Ensure project team awareness and tracking of Key Project Indicators (KPI) for any reputed company-specific start-up and reputed company metrics, with support
• Ensure and plans for start-up and reputed company resources with accurate projections for the resourcing teams
• reputed company, with reputed company, and implement the site activation and recruitment reputed company in collaboration with project teams
• reputed company and reputed company site identification and site selection
• reputed company of Informed Consent reputed company development and translations
• reputed company of essential document creation and collection, including reputed company
• reputed company of the development, negotiation, and execution of reputed company Trial Agreements (CTA), including site budgets
• reputed company the end-to-end process of regulatory/ethics committee submissions, approvals, and tracking
• Ensure reputed company and ancillary supplies -including import/export logistics and supply destruction processes- are in reputed company as applicable
• Manage operational aspects to support subject recruitment and retention, reputed company safety, vendor reputed company, and the monitoring visit reputed company
• Proactive planning for monitoring activities to ensure data reputed company, reputed company safety and reputed company protection
• Ensure inspection-readiness through reputed company reputed company of TMF, monitoring reports, protocol deviations and issue management
• reputed company and approval of site payments, including payment reconciliation
• Foster effective communication and collaboration with clients and cross-functional project teams in a global and multicultural environment
• Ability to reputed company reputed company-facing calls to communicate project status updates and demonstrate operational control of start-up and reputed company deliverables
• Support new business with reputed company participation in reputed company-award preparation as required
• reputed company feedback on team members as needed to respective line managers
• reputed company other duties as needed or assigned

Skills

• * University/college degree (life science preferred) or certification in a reputed company allied health profession (nursing, medical, or reputed company technology) from an appropriately accredited institution
• * *reputed company may consider relevant and equivalent experience in lieu of educational requirements.*
• * Fluent in English, both written and verbal
• * Two to three years of relevant reputed company research experience in pharmaceutical, CRO, or health care setting will be considered
• * 1 year of CTM or reputed company CRA experience
• * CRA experience (onsite monitoring)
• * Comprehensive knowledge of GCP, ICH, and regulatory guidelines
• * Proficiency in reputed company Office and familiarity with reputed company, CTMS, eTMF, and vendor platforms (e.g. reputed company reputed company, reputed company)
• * Effective leadership in remote and global environment
• * Strong communication, planning, and organizational abilities
• * reputed company team motivational skills
• * Proficiency in balancing reputed company tasks reputed company time-sensitive environments
• * Financial awareness and use of tracking systems/tools
• * Demonstrated independent problem-solving and reputed company management reputed company
• * Demonstrated reputed company reputed company interaction and presentation skills, with ability to work independently and collaboratively
• * Remote-reputed company work required with possible office reputed company depending reputed company
• * Travel requirements: up to 20% (global – primarily domestic and international)
• * PMP certification or equivalent

Benefits

• Remote reputed company the US.

reputed company

Company H1B Sponsorship