PSI CRO

Pharmaceutical

ClinicalRegionalProjectLead

$1500–2500k ~AI est. Bangkok, Bangkok, Thailand FULL TIME
The Brief

“Clinical Regional Project Lead at PSI CRO. Skills: Project management, Clinical Operations, Regional oversight. Streamline activities of project teams. Ensure consistency of Clinical Operations processes”

What You'll Achieve.

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

Industry & Context.

Pharmaceutical

What They're Looking For.

Must Have

MPharm, RN or university/college degree, Minimum 4 years’ site monitoring experience, At least 2 years’ experience as Lead Monitor, Experience supervising clinical project activities, Experience leading clinical project teams, Full working proficiency in English, Full working proficiency in Thai

Nice to Have

Experience in oncology, Experience in gastroenterology, Experience in infectious diseases, Experience in autoimmune diseases, Experience in rare disease indication, Experience as Lead Monitor in regional capacity

What You'll Do.

Streamline activities of project teams

Ensure consistency of Clinical Operations processes

Ensure meeting study milestones

Report study progress to clients

Report study progress to global stakeholders

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

Oversee site selection

Oversee site contractual negotiations

Oversee site budget negotiations

Supervise project team

Supervise site training

Perform field training of monitors

Ensure team compliance with training matrix

Supervise preparation of site visits

Supervise conduct of site visits

Supervise reporting of site visits

Review site visit reports

Ensure monitoring standards are met

Ensure reporting standards are met

Oversee investigator payments

Oversee site payments

Supervise project team preparation for audits

Supervise project team preparation for inspections

Supervise resolution of audit findings

Supervise resolution of inspection findings

Involved in regional project oversight

How You'll Work.

Team & Collaboration

Project teams; PSI support services; Clients; Global stakeholders

Communication Scope

Presentation skills; Customer-service skills

Process & Methodology

Project management

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