We have a current opportunity for a Clinical Project Manager on a 12-month contract-to-hire on a W2. The position will be based in Somerville, New Jersey. For further information about this position please apply.
Contract Length: 1 year; will convert to FTE
Location: Somerville, NJ
Type: Hybrid on W2, 2-3 days on-site
Job Description / Summary
Responsible for initiating, planning, executing, monitoring and controlling, and closing all aspects of a clinical trial. The role includes dealing with budgets, FTEs, and knowledge of data visualization. The Clinical Project Manager serves as a liaison between the study sponsor and the project team and the clinical trial site(s).
Job Requirements:
- Manage study scope, budget, and timelines
- Interacting with CROs, serve as point of contact for sponsor and study team
- Knowledge of applicable SOPs, guidelines and study procedures
- Report study performance through Project Review meetings
- Participate in ongoing training
- Lead project meetings
- Delegate activities as appropriate
- Monitor study performance
- Proactively identify risks and manage them
- Develop/review documents such as study plans, informed consent forms, and protocols
- Manage the study budget and participate in routine budget meetings
- Continuously monitor scope and initiate the change order process for out of scope activities
Education/Skills:
- Bachelor's Degree in a scientific or engineering field
- At least a minimum of 5 years of clinical trial experience within a pharmaceutical, biotechnology or CRO
- At least 3 years of Project Management experience
- PMP-certified preferred
- Experience with Phase IV interventional blood studies desired
- Excellent verbal and written communication skills
- Demonstrated good management skills
- Detail-oriented and excellent organizational skills, tracking and time management skills
- Up-to-date knowledge of GCP/ICH Guidelines
- Strong computer skills, e.g., proficient in MS Word, Excel, Outlook, and PowerPoint
- Knowledge of ICH/GCP and applicable regulatory requirements
- Experience with training and mentoring CRAs
- Good understanding of the drug development process
