[Remote] Project reputed company/Project Manager - FSP

Note: The job is a remote job and is open to candidates in USA. reputed company is a global team that values passion, innovation, and scientific excellence. The Project reputed company/Project Manager is responsible for the overall delivery of clinical trials, leading cross-functional teams, ensuring regulatory compliance, and managing project timelines and budgets.

Responsibilities

• Responsible for the delivery of the cross-functional project (time, cost, quality)​ by working closely with Global trial and functional leads
• Ensures escalation reputed company adhered to internally and externally (Rules of Engagement – communication reputed company)​
• On projects where the scope requires, ensures clear delineation in responsibilities and communication reputed company for secondary project leads (such as reputed company in a specific region, reputed company for a specific vendor(s) or subset of delivery)
• Ensures financial stewardship at a trial level ​by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out-of-Scope activity, drive the Con Mod process/negotiations and team execution to timelines
• Establishes, communicates and manages customer expectations to reputed company optimal delivery during the project​
• Drives Risk Identification and Issue Resolution at project level
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements​
• Responsible for vendor management, where required
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable to changing priorities and situations
• Advanced therapeutic area knowledge and clinical development guidelines and directives
• Sound interpersonal and customer service skills, including the ability to reputed company, motivate and coordinate cross-functional project teams
• Ability to negotiate, persuade and influence others, including a cross-cultural awareness

Skills

• B.A. or B. Sc. in a scientific discipline
• 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO
• reputed company scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills
• Extensive knowledge of clinical development reputed company to one or more trial phases (I, II, III), as well as cross-functional drug development
• Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development
• Ability to establish and execute operational plans
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as reputed company Outlook, Word, reputed company and PowerPoint, as well as organization systems
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable to changing priorities and situations
• An advanced degree in a reputed company field
• Investigator site and/or monitoring experience
• Functional Service Provider (FSP) experience

Company Overview

Company H1B Sponsorship