Project Manager
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Job Description
Project Manager leading sponsor relationships and clinical trials at Parexel, a global clinical research organization. Managing study start-up, budgets, risks, timelines, compliance, and closeout.
Responsibilities:
- Own the sponsor relationship and manage sponsor communication
- Serve as the central point of contact and escalation for functional teams
- Communicate project progress, risks, and solutions to sponsors and internal teams
- Lead regular sponsor and project team meetings
- Review pre-award materials and attend strategy, Bid Defense, and handover meetings
- Develop project management strategies
- Manage study start-up activities and implement best practices
- Oversee site selection strategy and review project contracts and budgets
- Set up project teams and systems
- Manage IRB/EC and RA approval processes
- Lead internal and sponsor kick-off meetings
- Lead projects to completion within budget and schedule
- Ensure contract specifications are met and project tracking is maintained using CTMS
- Monitor study timelines, recruitment, retention, and data cleaning
- Prepare for audits and inspections
- Manage project budgets
- Oversee administrative closeout and project documentation archiving
- Lead end-of-study meetings and document lessons learned
- Identify project risks and implement contingency plans
- Mitigate risks and keep clients informed throughout the study lifecycle
- Contribute to SOP development
- Provide oversight and training to Associate Project Managers and Project Assistants
Requirements:
- 3 years of Project Management experience with Parexel or 3 to 5 years in related 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-related field or equivalent work experience
- Advanced degree preferred
- Additional business degree or PMP certification is an advantage
- Scientific, medical, or pharmacology background is an advantage
- Leadership skills for leading virtual teams across locations and cultures
- Negotiation and influence skills
- 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
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