The Senior Clinical Project Manager (Sr. CPM) is responsible for overseeing and managing clinical trials from initiation through to completion. This role ensures that clinical projects are executed in compliance with regulatory requirements, within budget, and on time.
Qualifications:
- Bachelor's degree in life science/related field, advanced degree preferred
- Minimum of 5+ years of experience in clinical project management, with at least 3+ years in a leadership or senior role
- 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
- Excellent organizational and time-management skills with the ability to manage multiple projects simultaneously
- Superior communication and interpersonal skills, with a proven ability to collaborate with diverse teams and stakeholders
- Proficiency in project management software and clinical trial management systems
- Ability to travel domestically and internationally
Responsibilities:
- Lead and manage all phases of clinical trials, including planning, execution, monitoring, and close-out
- Develop detailed project plans, timelines, and budgets
- Oversee and coordinate cross-functional teams, including clinical research associates (CRAs), data managers, biostatisticians, and other team members. Provide leadership and mentorship to junior staff
- Able to motivate a team to work effectively in a changing and fast-paced environment
- Ensure trials comply with Good Clinical Practice (GCP), regulatory requirements, and company policies
- Prepare and review regulatory documents and submissions
- Act as the main point of contact for internal and external stakeholders. Communicate project status, issues, and milestones effectively
- Identify potential risks and develop mitigation strategies. Address issues proactively to ensure project goals are achieved
- Develop, track, and manage project budgets. Allocate resources effectively and ensure financial oversight
- Organize and run assigned clinical study team meetings and teleconferences
- Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
- Escalate pertinent CRA performance and site compliance issues when necessary
- Ensure accurate and timely collection, analysis, and reporting of clinical trial data. Maintain data integrity and compliance throughout the trial
- Monitor and ensure adherence to protocol and quality standards
What We Offer:
- Competitive salary
- Opportunity to work on cutting-edge projects and make a significant impact
- Supportive and dynamic work environment
- Professional development and growth opportunities