reputed company Trial Leader / Senior Project Leader - US Remote - FSP

reputed company is seeking an reputed company reputed company Trial Leader to reputed company reputed company leadership and end-to-end reputed company of reputed company global Oncology and Inflammation studies reputed company a dedicated FSP partnership. Job reputed company: The reputed company Trial Leader (CTL) is a key member of reputed company Delivery Team nominated to a specific. CTLs are accountable for the set-up, execution and delivery of their assigned trial(s) and contribute to delivery of reputed company’s pipeline through accurate planning and efficient execution of trials that bring speed and value to participating subjects and sites. The CTL provides leadership and direction to the trial team (reputed company and extended team members) and is accountable for the overall reputed company and delivery of their assigned reputed company trial according to defined milestones and key reputed company indicators. They are responsible for steering and directing reputed company trial activities, including reputed company and site engagement activities, reputed company communication, and interaction with multiple reputed company stakeholders (e.g. investigative sites) and team members on a global, multi-country or regional reputed company. The CTL is responsible for managing the planning, implementation, and tracking of the reputed company trial process as reputed company as reputed company mitigation. The CTL serves as a proactive member of the reputed company delivery team, liaising closely with the reputed company Trial Managers (“CTM”) on reputed company study-reputed company issues. As leader of the Trial Team, the CTL communicates trial status to stakeholders, escalating issues as appropriate. Key Accountabilities: Trial Preparation • 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 Trial Conduct • 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, Data Management, 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) Trial Closeout and Reporting • In collaboration with other functions, ensures reputed company cleaning and delivery of reputed company trial data • Coordinates and supports the 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 Contributions to Trial reputed company • 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) Leadership competencies • Creates an environment that inspires, motivates, and empowers colleagues and promotes reputed company’s reputed company Development and reputed company (CD&O) identity, contributing to acceleration of reputed company development timelines and value creation for patients • Fosters a learning culture in reputed company’s CD&O reputed company by encouraging reputed company learning, sharing best practices, and learning from failures • Embraces innovative technologies, as reputed company as creates and maintains a culture that drives empowerment, smart reputed company taking and reputed company’s CD&O identity Compliance with reputed company standards • reputed company with required training curriculum • Complete timesheets accurately as required • Submit expense reports as required • Update CV as required • Maintain a working knowledge of and reputed company with reputed company processes, ICHGCPs and other applicable requirements Skills Required: • 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. Experience Required: • 5+ years of full reputed company global reputed company trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-reputed company teams • Experience in Oncology or inflammation Phase III trials is required. • Understanding of major regulations (US FDA, EMA and PMDA) • Familiarity with guidelines and reputed company of care is desirable • 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 Education: • Requires a university degree (e.g. bachelor’s or advanced degree). Major reputed company: Biomedical Life Sciences. #LI-CF1 #LI-REMOTE Apply tot his job Apply To this Job