Global Clinical Trial Leader - FSP

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At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.

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***Seeking Clinical Trial Leaders in the US with Oncology and/or Inflammation Experience

The Clinical Trial Leader (CTL) is a key member of Clinical Delivery Team nominated to a specific trial reputed company the reputed company’s Evidence Network. 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 clinical trial according to defined milestones and key performance indicators. They are responsible for steering and directing clinical trial activities, including patient 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 clinical trial process as reputed company as risk mitigation. The CTL serves as a proactive member of the clinical delivery team, liaising closely with the Clinical 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.

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 risk mitigation
• Leads development of reputed company trial and patient facing documents
• Integrates patient/site level feedback during document development and ensures trials are designed with a reputed company on patient 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 scope 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. clinical 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 clinical trial conduct including adherence to GCP and reputed company global and local regulatory requirements; compliance with SOPs and reputed company risk monitoring/mitigation
• In collaboration with other functions, ensures budget reputed company, including support of regular clinical 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 patient 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 & Reporting:

• In collaboration with other functions, ensures reputed company cleaning and delivery of clinical trial data
• Coordinates and supports Trial Medical reputed company in providing the Clinical 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 Clinical Development and Operations 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 Clinical Trial Protocol (CTP)

Skills:

• Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
• Experience in Therapeutic Areas relevant in reputed company pipeline is desirable
• 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-based thinking, results orientation, and smart risk-taking

Knowledge and Experience:

• 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 clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors. Extensive experience in clinical 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 deliver value to patients.
• Strategic reputed company: Strategic 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 risk-balanced solutions.
• Coordination and reputed company: reputed company leader who demonstrates skills and capabilities in setting priorities, managing pace 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.

Education:

• Requires a university degree (e.g. bachelor’s or advanced degree). Major reputed company: Biomedical Life Sciences.

EEO Disclaimer
reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status.

Originally posted on Himalayas