Senior Project Manager
$147,300–$220,900 year
Remote
Job Summary
Plan, direct, and coordinate clinical study projects to ensure objectives of quality, scope, cost, and time are accomplished. Serve as the primary point of contact and escalation point to the client while managing the study budget and financial health, including oversight of project profitability and accurate billing. Develop comprehensive project plans with proactive risk management and mitigation to guide trial execution, ensuring eTMF inspection readiness and implementing corrective action plans for quality findings. Maintain integrated collaboration with clinical operations and functional teams, leading internal and client meetings to set expectations and relay protocol issues. Prepare status updates reporting on key performance indicators and offer solutions as they arise, while conducting formal presentations for bid defenses and supporting business development activities.
Required Qualifications
- Bachelor's degree or equivalent combination of education/experience in science or health-related field
- Advanced degree
- Minimum of 7 years of clinical research experience
- Minimum of 4 years of direct project management experience
- Experience in managing complex and global trials
- Ability to travel domestically and internationally including overnight stays
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Experience with Microsoft Project
- Experience with eTMF
- Experience with EDC
- Experience with CTMS
- Proven communication and interpersonal skills
- Proven organizational skills
- Attention to detail
- Customer service demeanor
- Demonstrates knowledge of ICH-GCP
- Knowledge of relevant Precision SOPs
- Ability to implement ICH-GCP and Precision SOPs
- Direct work experience in a global, cross-functional project management environment
- Good understanding of cross-functional management
- Good understanding of project planning
- Good understanding of risk management
- Good understanding of change management
- Awareness of appropriate escalation
- Proven experience in strategic planning
- Proven experience in risk management
- Proven experience in change management
- High level of integrity
- Ability to lead and inspire excellence within a study team
- Ability to create an environment where study team members have a sense of ownership
- Results oriented
- Accountable
- Motivated
- Flexible
- Proven time management
- Proven negotiation
- Proven critical thinking
- Proven decision making
- Proven analytical skills
- Proven interpersonal skills
- Proven presentation skills
- Proven verbal communications skills
- Proven written communications skills
- Good understanding of project management software
- In depth proven experience in pharmaceutical research
- In depth proven experience in device research
Desired Qualifications
- Radiopharmaceutical trial experience
- Experience with oncology
- Experience with cell and/or gene therapy
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