PSI CRO

Clinical Research

RegionalProjectLead

$135–195k ~AI est. United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for mid candidates.

The Brief

“Regional Project Lead at PSI CRO. Skills: Clinical trial management, Project management, Operations management, Cross-functional coordination. Oversee project teams. Manage project teams”

What You'll Achieve.

Ensure meeting study milestones; Ensure project timelines are met; Ensure subject enrollment targets are met

Industry & Context.

Clinical Research
Problems you'll solve

Issue resolution

What They're Looking For.

Must Have

College/University degree in Life Sciences, Prior experience in Clinical Research, Prior on-site monitoring experience, Experience as Study Manager/Clinical Trial Manager, Ability to supervise project activities as Regional Lead, Experience in Oncology, Full working proficiency in English, Proficiency in MS Office applications, Proficiency in MS Project

Nice to Have

Experience in GI

What You'll Do.

Oversee project teams

Coordinate project activities

Ensure process consistency

Ensure study milestones are met

Act as project management contact

Perform study status review

Perform progress reporting

Collect project status updates

Report project status updates

Develop project planning documents

Update project planning documents

Develop essential study documents

Update essential study documents

Develop project manuals/instructions

Update project manuals/instructions

Ensure project timelines are met

Ensure subject enrollment targets are met

Coordinate tracking systems maintenance

Coordinate site contractual startup

Coordinate budget negotiations

Establish communication lines

Supervise team performance

Identify resourcing issues

Escalate resourcing issues

Resolve resourcing issues

Identify performance issues

Escalate performance issues

Resolve performance issues

Conduct therapeutic area training

Supervise therapeutic area training

Prepare Investigator training presentations

Conduct Investigator training

Ensure team compliance with training matrix

Perform field training of Monitors

Supervise preparation of site visits

Supervise conduct of site visits

Supervise reporting of site visits

Oversee investigator payments

Oversee site payments

Oversee CRF data retrieval

Oversee query resolution process

Supervise team preparation for audits

Supervise team preparation for inspections

Supervise resolution of audit findings

Supervise resolution of inspection findings

Coordinate conduct of supervised monitoring visits

Review site visit reports

Ensure monitoring standards are met

Ensure reporting standards are met

Coordinate preparation of Regulatory submissions

Coordinate preparation of Ethics Committee submissions

Oversee safety information flow

Participate in feasibility research

Review project related expenses

Approve project related expenses

How You'll Work.

Team & Collaboration

Project teams; PSI support services; Clinical project team members; Project team members; Monitors; Investigators; Regulatory; Ethics Committee

Communication Scope

Presentation skills; Customer-service skills

Process & Methodology

Project management, Clinical trial management, Planning, Implementation, Reporting, Timeline management, Budget negotiation, Performance management, Training, Monitoring, Audits, Inspections, Submissions

Full Job Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. The Regional Project Lead is a senior level clinical trial manager who oversees, manages, and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level. * Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents) * Acts as primary or secondary project management contact for the project team and PSI support services in designated countries * Performs study status review and progress reporting (if delegated by the Project Manager) * Collects and reports project status updates for designated regions, both internally and externally * Develops and updates project planning documents, essential study documents and project manuals/ instructions * Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members * Ensures that the project timelines and subject enrollment targets are met in designated countries * Coordinates maintenance of study-specific and corporate tracking systems * Coordinates site contractual startup and budget negotiations * Establishes communication lines within the project team and supervises clinical project team members’ performance * Identifies, escalates and resolv

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