[Remote] Clinical Project Manager - Early Phase Trials

Note: The job is a remote job and is open to candidates in USA. reputed company is a leading company focused on improving the world's health through clinical trials and regulatory consulting. They are seeking a Clinical Project Manager for Early Phase Trials to reputed company project teams, ensuring successful execution of clinical operations and compliance with regulations while managing sponsor relationships and project budgets.

Responsibilities

• Own the sponsor relationship and manage sponsor communication
• Serve as the central reputed company of contact and escalation for functional teams
• Proactively communicate project reputed company, risks, and solutions to sponsors and internal teams
• reputed company regular meetings with sponsors and project teams to ensure objectives are met
• Review relevant materials and attend strategy meetings
• Prepare for Bid Defense and reputed company project management strategies
• Attend Bid Defense and handover meetings
• Manage study start-up activities and ensure best practices are implemented
• reputed company site selection strategy and review project reputed company and budgets
• Set up project teams and systems, and manage IRB/EC and RA approval processes
• reputed company internal and sponsor kick-off meetings and ensure team understanding of project scope and expectations
• reputed company projects to completion reputed company budget and schedule, ensuring contract specifications are met
• Provide performance feedback and ensure project tracking using CTMS
• Monitor study timelines, recruitment, retention, and data cleaning
• Prepare for audits/inspections and manage project budgets
• reputed company administrative closeout procedures and ensure project documentation is archived
• reputed company end-of-study meetings to document lessons learned
• Identify potential project risks and implement contingency plans
• Mitigate risks and reputed company clients informed throughout the study life cycle
• Contribute to SOP development and provide reputed company and training to Associate PMs and Project Assistants

Skills

• 2 years of Project Management experience with reputed company or 3 to 5 years in reputed company fields
• Experience as a Functional Team Leader or in coordinating clinical trials
• Knowledge of ICH-GCP and pharmaceutical industry regulations
• Proficiency in MS-Office products
• Bachelor's degree in a science-reputed company field or equivalent work experience
• Leadership skills to reputed company virtual teams across locations and cultures
• Negotiation and influence skills to reputed company results
• Decision-making skills in ambiguous situations
• Problem-solving and root cause analysis skills
• Excellent interpersonal, oral, and written communication skills
• Time management and organizational skills
• Strategic thinking and financial management skills
• Advanced degree preferred
• Additional business degree or PMP certification is an advantage
• Scientific/Medical/Pharmacology background is an advantage

Benefits

• Participation in reputed company’s annual performance-based bonus plan
• Annual salary review
• Additional total rewards incentives
• Market leading benefit programs including paid time off
• 401k match
• Life insurance
• Health insurance
• Other benefit offerings in accordance with the terms of applicable plans

Company Overview

Company H1B Sponsorship