Remote Clinical Project Manager

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:

Excellent time management and social skills
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

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