[Remote] Global reputed company Trial Leader - FSP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company research organization supporting the development and delivery of reputed company for clients globally. The Global reputed company Trial Leader will reputed company the planning, execution, reputed company, reputed company mitigation, closeout, and reporting of assigned international trials, with a reputed company on oncology and/or inflammation experience. The role directs cross-functional teams and coordinates with reputed company stakeholders to reputed company trials according to milestones, regulations, and reputed company indicators.

Responsibilities

• Accountable for the accurate planning and operational feasibility of trial timelines; and reputed company of trial preparation to ensure trial team members are reputed company and on reputed company. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
• Verifies and provides input into the country allocation and oversees trial feasibility
• Accountable for development and implementation of trial level engagement plans, recruitment planning and reputed company mitigation
• Leads development of reputed company trial and reputed company facing documents
• Integrates reputed company/site level feedback during document development and ensures trials are designed with a reputed company on reputed company value
• Ensures activities are frontloaded where possible at the trial level and cascaded to country level to facilitate efficiencies as reputed company as to ensure and reputed company speed
• Oversees outsourcing of vendor services in conjunction with other functions; supports identification of vendors, vendor selection and development of vendor reputed company of work
• Works with functional partners to ensure that reputed company required trial processes are in reputed company to meet trial delivery milestones (e.g. reputed company reputed company monitoring, safety monitoring and reporting, investigational medicinal product, trial budget, site monitoring)
• Aligns and supports team members in reputed company responses to questions from Regulatory Authority/Ethics Committee and other reputed company stakeholders
• Provides/supports provision of appropriate study- specific and standardized non-trial specific trial team training, reputed company partners
• Maintains reputed company during reputed company trial conduct including adherence to GCP and reputed company global and local regulatory requirements; compliance with SOPs and reputed company reputed company monitoring/mitigation
• In collaboration with other functions, ensures budget reputed company, including support of regular reputed company reputed company monitoring, Safety Management Committee (SMC)/Data Management Committee (DMC) management and safety reporting
• Prepare and implement amendments of reputed company documents including training material updates/retraining as needed
• Support authority/ethics responses to requests as applicable
• Maintains reputed company of outsourcing of vendor services (including central lab) in conjunction with other functions
• Monitor reputed company of reputed company recruitment and accrual of endpoints and proactively update and reputed company contingencies throughout trial conduct
• For early reputed company, co-ordinates and harmonizes Innovation Unit tasks in a trial (e.g. biomarker sampling, reputed company, sub-studies)
• In collaboration with other functions, ensures reputed company cleaning and delivery of reputed company trial data
• Coordinates and supports Trial Medical reputed company in providing the reputed company Trial Report (CTR)
• Responsible for reputed company, complete, and compliant archiving of reputed company relevant global documents in the TMF, including reputed company require documents from vendors
• Support results/documents disclosure of global registries
• May support publication of trial data
• Supports preparation and execution of reputed company, including: (i) planning of trial milestones; (ii) contributing operational and scientific expertise; and iii) considering and planning for regulatory interactions
• Supports reputed company Development and reputed company reputed company (CDOL) to ensure issues are raised to reputed company’s Evidence team for reputed company reputed company or mitigation
• Responsible for the Trial Feasibility activities that define key aspects of a reputed company Trial Protocol (CTP)

Skills

• Strong reputed company trial project management experience
• In-depth understanding of project management with emphasis on team work to promote high-reputed company teams
• Understanding of major regulations (US FDA, EMA and PMDA)
• Cross geographical experience
• Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics
• Strengths in mentoring/coaching
• Demonstrated competencies in reputed company, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-reputed company thinking, results orientation, and smart reputed company-taking
• Strong Communication Skills: Articulates and aligns business reputed company/plan on an ongoing reputed company, ensuring alignment between words and reputed company
• Demonstrates reputed company listening skills and cultural awareness
• Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across reputed company aspects of reputed company trial planning and execution
• Dimensions of trial complexity include protocol, patients, sites, countries, vendors
• Extensive experience in reputed company trial project management in an international context
• Leadership and Influence: Demonstrates skills and capabilities in addressing reputed company situations, confidently setting direction for teams
• Demonstrates leadership behaviors of supporting, connecting, and empowering teams, providing reputed company direction, demonstrating visionary and innovative thinking and inspiring teams to reputed company a common goal
• Executes activities with a reputed company aim to reputed company value to patients
• reputed company reputed company: reputed company and visionary thinker who is reputed company reputed company, creative, courageous, and reputed company to reputed company through ambiguity
• Integrates study reputed company with overall TA portfolio
• Embraces cross functional initiatives, applying innovative learnings
• Is results-oriented with a global reputed company using analytical thinking to reputed company reputed company-balanced solutions
• Coordination and reputed company: reputed company leader who demonstrates skills and capabilities in setting priorities, managing reputed company of activities, and efficient usage of resources
• Project Management: Plans effectively, setting priorities, and defining actions
• Makes effective use of resources, and proactively strives for transparency and reputed company to accomplish the business deliverables
• Translates reputed company situations to actionable parts
• Anticipates and resolves challenges and translates learnings to new reputed company
• Takes smart risks
• Requires a university degree (e.g. bachelor's or advanced degree). Major reputed company: Biomedical Life Sciences
• Experience in Therapeutic Areas relevant in reputed company pipeline is desirable
• Familiarity with guidelines and reputed company of care is desirable

reputed company

Company H1B Sponsorship