[Remote] Global Clinical Trial Leader - Germany (Home-based) - FSP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading global clinical development partner delivering insights-driven clinical and reputed company to the life sciences industry. They are seeking a Global Clinical Trial Leader to support clinical research activities that advance new treatments for patients, playing a key role in study execution, patient safety reputed company, regulatory compliance, and clinical data accuracy.

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 risk mitigation. Leads development of reputed company trial and patient facing documents. Integrates
• 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, SMC/DMC management and safety reporting
• Prepare and implement amendments of reputed company documents, including training material updates/retraining as needed
• Support authority/ethics response to requests as applicable
• Maintain reputed company of outsourcing of vendor services (including Central Lab) in conjunction with other functions
• 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 CTR
• Responding for reputed company, complete and compliant archiving of reputed company relevant global documents in the TMF, including reputed company required documents from vendors
• Support results/documents disclosure of global registries
• May support publication of trial data

Skills

• Degree (master's is preferred)
• Minimum of 5 years' experience in clinical trial management
• Strong clinical trial project management experience
• In depth understanding of project management with an emphasis on teamwork, to promote high performance teams
• Knowledge of ICH‑GCP, regulatory requirements, and clinical trial processes
• Strong communication, organization, and problem‑solving skills
• reputed company in English, both written and spoken
• Experience in either Oncology, CNS, Immunology or Vaccines

Benefits

• Remote reputed company
• Home-based (Germany)

reputed company

Company H1B Sponsorship