Clinical Project Manager at KlinEra Global Services Inc
San Jose, CA
About the Job
Qualifications
- Bachelor's degree in life science/related field, advanced degree preferred
- Minimum of 5+ years in clinical research industry
- Proven experience as a clinical project manager or similar role in the pharmaceutical, biotechnology, or medical device industry
- In-depth knowledge of clinical research, FDA regulations, and ICH/GCP guidelines
- Strong leadership, organizational, and time management skills
- Ability to manage multiple priorities and work effectively in a team environment
Responsibilities
- Develop comprehensive project plans that outline project scope, objectives, timelines, resources, and budget requirements
- Coordinate internal resources and third parties/vendors for flawless execution of projects
- Ensure all projects are delivered on-time, within scope, and within budget
- Identify and manage project risks and issues effectively
- Implement risk mitigation strategies to minimize project risks
- Ensure all project activities comply with relevant regulations and quality standards
- Monitor and report on project progress to stakeholders
- Lead and motivate project team members and influence them to take positive action and accountability for their assigned work
- Facilitate effective communication and collaboration among project team members, stakeholders, and sponsors.
- Manage stakeholder expectations and resolve any issues that arise
- Prepare and maintain project documentation, such as project plans, status reports, meeting minutes, and correspondence
- Provide regular updates to management and stakeholders on project progress