Clinical Project Manager

Summary

The role of this Remote Clinical Project Manager (CPM) is to ensure that the project is planned and conducted in accordance with relevant rules and regulations. The CPM will also need to ensure overall success of the study trial, ensuring that the project is planned and conducted in accordance with all relevant rules and regulations, including the contract, company SOPs, ICH-GCP, FDA and other regulatory guidelines as applicable. The CPM will also ensure that the project meets quality, budget, and timeline objectives, including identifying project milestones and key deliverables.

To be successful in this position the CPM must be comfortable collaborating and communicating with a variety of colleagues and clients and demonstrate flexible and creative leadership. 

Qualifications

• Bachelor's degree in a life science, nursing, computer science or related discipline OR RN/LPN with related experiences
• Familiarity with database program(s), data management, medical terminology; experience working with clinical trial data
• Knowledge of FDA regulations and GCP
• Accuracy, attention to detail and ability to set priorities and meet deadlines
• Proficient Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel with the ability to create and/or utilize V-lookups, pivot tables, formulas, manipulating data and creating reports
• Other Skills required:
  1. Excellent time management and social skills
  2. Highly motivated with a phenomenal eye for detail

WORK ENVIRONMENT

• This is a remote position with some travel
• Must have a dedicated office space to work remotely when not onsite
• Must be willing to travel throughout North America, and potentially outside of North America (on occasion) in order to perform work duties
• Work environment will include hospitals, medical clinics, and other medical institutions
• Must be willing to travel by plane, train, automobile, or as needed depending on work locations
• Must be willing to adapt to frequent last-minute travel and schedule changes, as well as itinerary changes to meet the needs of the company and study
• Willing to wear Personal Protective Equipment (PPE) as required when visiting medical facilities

Duties and Responsibilities

Clinical Project Manager is responsible for: overall success of the study trial, including the following:

• Ensuring that the project is planned and conducted in accordance with all relevant rules and regulations, including the contract, company SOPs, ICH-GCP, FDA and other regulatory guidelines as applicable
• Ensuring that the project meets quality, budget, and timeline objectives, including identifying project milestones and key deliverables
• Oversight of functional groups and all clinical monitoring team members throughout the duration of each clinical trial
• Ensuring clear client and internal team communication, process documentation and compliance with procedures set forth by Tranquil Clinical research and its clients
• Oversight and management of all vendors, including contract negotiations as applicable
• Setting up CTMS and other study systems for the project and ensure that data is captured/entered in a timely manner
• Developing and implementing the project plan, and review/approval all study plans
• Training, supporting, guiding, and motivating the project team
• Coordinating the project team and its activities to achieve contracted deliverables
• Monitoring and triggering investigator payments on a timely basis
• Ensuring project financial tracking
• Preparing Weekly and Monthly Status Reports (as required)
• Adjusting resources as needed to meet the Project Plan
• Identifying out of scope work and initiating the change order process
• Set-up the project team
• Identify and document Client requirements
• Identify project milestones and key deliverables
• Develop and implement the Project Plan
• Ensure all appropriate departmental plans are in place
• Develop and implement the communications and reporting plan
• Review all appropriate study documentation
• Set-up CTMS for the project with Executive Super User and ensure timely data entry
• Identify, train, support, guide and motivate the project team
• Coordinate project team and its activities to achieve contracted deliverables
• Manage Client expectations
• Maintain regular contact with Client
• Initiate and manage Client invoicing process
• Review vendor invoices
• Monitor and trigger investigator payments on a timely basis
• Update financial tracking
• Maintain project profitability
• Weekly and Monthly Status Reports (if required)
• Adjust resources as needed to meet the Project Plan
• Identify out of scope work
• Initiate the change order process