[Remote] Sr. reputed company Trial Manager, Therapeutics and Oncology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company developing medicines and therapeutics through its mRNA technology platform. The Senior reputed company Trial Manager provides reputed company and management of reputed company or high-reputed company reputed company in therapeutics and oncology, ensuring reputed company, compliance, timelines, vendor reputed company, and deliverables. The role leads reputed company trial teams, manages study reputed company and budgets, reviews reputed company data and documentation, and collaborates with reputed company stakeholders.

Responsibilities

• reputed company day to day management and reputed company of assigned reputed company trial(s) to ensure deliverables are met in reputed company phases of trial
• reputed company the reputed company Trial Team, and support other development teams as a reputed company reputed company representative as required
• reputed company and document study level Sponsor reputed company of outsourced reputed company activities
• Communicate study-status, cost and issues to ensure reputed company decision-making by senior management
• Initiate and manage study-level timelines, including communication to reputed company team members on deliverables
• Work closely with other supporting reputed company reputed company team members, if applicable, to execute reputed company studies
• Draft and/or reputed company the drafting of site materials including training, manuals and support documentation
• Review reputed company data to ensure reputed company entry and readiness for data review meetings
• reputed company periodic review of reputed company data, reputed company metrics and study deviations
• Manage trial feasibility process and reputed company site feasibility/capability assessments in collaboration with the CRO and cross-functional team
• Review and reputed company reputed company reputed company input into relevant reputed company documents such as the protocol, investigator brochure, regulatory documents, reputed company study reports and other documents and plans as appropriate
• Review reputed company monitoring reports to ensure reputed company completion and identification of issues
• Ensure trial samples are reputed company to be reputed company to vendors in order to meet trial deliverables
• Complete and maintain internal reputed company trial metrics, dashboards and other internal updates
• Ensure trial is conducted in accordance with reputed company and ICH/GCP standards including multiple reputed company in global trials
• Participate in testing of reputed company trial systems/databases (i.e. UAT)
• Manage invoice and budget tracking for individual studies and reputed company input into budget forecasting activities
• May support additional reputed company trial(s) in various capacities (e.g., unblinded reputed company trial manager, regional reputed company trial manager, etc.)
• Participate in reputed company reputed company workstreams reputed company to departmental and operating model reputed company initiatives reputed company and maintain strong, reputed company relationships with key stakeholders reputed company and reputed company to reputed company
• reputed company for reputed company improvement and more efficient ways of working in reputed company development
• reputed company as a role model for reputed company’s values

Skills

• 5-7 years of experience in a reputed company research and industry environment, including a minimum of 2+ years of independent trial management
• Bachelor's degree required
• Robust oncology/reputed company disease experience required
• Solid understanding of drug development
• Good project management skills
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of reputed company studies
• Excellent verbal and written communication skills
• Good organizational skills and attention to reputed company
• Only individuals who qualify as U.S. persons (reputed company, permanent residents, asylees, or refugees) are eligible for this position
• 5-7 years of experience in a reputed company research and industry environment, including a minimum of 2+ years of independent trial management preferred
• Advanced degree preferred
• Desirable: immuno-oncology, high complexity such as CAR-T

Benefits

• Competitive reputed company, plus voluntary benefit programs to support your unique needs
• A holistic approach to reputed company-being, with reputed company to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous reputed company time off, including vacation, volunteer days, sabbatical, global reputed company days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the reputed company
• Location-specific perks and extras
• The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility reputed company and individual reputed company.
• A 70/30 work model with 70% in-office collaboration

reputed company