PSI CRO
Pharmaceutical
ClinicalRegionalProjectLead
Neural analysis suggests this role is
optimal for mid candidates.
“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 across regions”
What You'll Achieve.
Meeting study milestones; Timely services
Industry & Context.
Regional oversight for APAC
What They're Looking For.
Must Have
MPharm, RN or university/college degree in Life Sciences or equivalent, Minimum 4 years site monitoring experience, Minimum 2 years experience as Lead Monitor, Experience supervising clinical project activities, Experience leading clinical project teams, Full working proficiency in English
Nice to Have
Experience as Lead Monitor in regional capacity, Experience in oncology, Experience in gastroenterology, Experience in infectious diseases, Experience in autoimmune diseases, Experience in rare disease indication
What You'll Do.
Streamline activities of project teams
Ensure consistency of Clinical Operations processes across regions
Ensure meeting study milestones by project teams
Report study progress to clients and 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 maintenance of tracking systems
Oversee site selection
Oversee site contractual negotiations
Oversee site budget negotiations
Supervise project team training
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 for APAC
How You'll Work.
Team & Collaboration
Project teams; PSI support services; Clients; Global stakeholders
Communication Scope
Presentation; Reporting
Process & Methodology
Project management
Full Job Description
PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications. In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. More than 25% of our colleagues have been with us for over 10 years, contributing to our long-standing traditions and history. At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally. We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry. In this role you will streamline activities of project teams and ensure consistency of Clinical Operations processes across regions. You will ensure meeting study milestones by project teams on a country level, report study progress to clients and global stakeholders. The scope of responsibilities will include: * Act as project management contact for the project team and PSI support services. * Perform study status review and progress reporting, collect and report project status updates. * Develop and update project planning documents, essential study documents and project manuals/ instructions. * Ensure that the project timelines and subject enrollment targets are met. * Coordinate maintenance of study-specific and corporate trac
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