Clinical Regional Project Lead

PSI CRO AG

. Streamline activities of project teams and ensure consistency of Clinical Operations processes across the Asia Pacific region .

Posted 11/2/2026full-timeRemote • MalaysiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical project management, ensuring compliance with study protocols and timelines while effectively leading project teams. Proficient in site monitoring and oversight, with strong communication and organizational skills to manage stakeholder expectations.

Highest-signal resume keywords

Clinical Project ManagementSite Monitoring ExperienceLead Monitor ExperienceTeam LeadershipProficiency in MS Office

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Operations ProcessesStudy Status ReviewsProject Planning DocumentsSite Selection and StartupBudget NegotiationsMonitoring StandardsAudit PreparationStudy Milestones ManagementSubject Enrollment TargetsProject Tracking Systems

Soft Skills

Communication SkillsPresentation SkillsCustomer-Service SkillsTeam BuildingOrganizational Skills

Tools & Technologies

MS OfficeMS Project

Certifications & Qualifications

MPharmRNUniversity/College Degree in Life Sciences

Industry Keywords

OncologyGastroenterologyInfectious DiseasesAutoimmune DiseasesRare Disease Indications

About the role

Key responsibilities & impact

Streamline activities of project teams and ensure consistency of Clinical Operations processes across the Asia Pacific region
Ensure study milestones are met by project teams at country level
Report study progress to clients and global stakeholders
Act as project management contact for the project team and PSI support services
Perform study status reviews and progress reporting
Collect and report project status updates
Develop and update project planning documents, essential study documents, and project manuals/instructions
Ensure project timelines and subject enrollment targets are met
Coordinate maintenance of study-specific and corporate tracking systems
Oversee site selection and startup, and site contractual and budget negotiations
Supervise project team and site training, including field training of monitors
Ensure team compliance with project-specific training matrix
Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits
Review site visit reports and ensure monitoring and reporting standards are met
Oversee investigator and site payments
Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings
Participate in regional project oversight for APAC as needed

Requirements

What you’ll need

MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience
Minimum 4 years’ site monitoring experience
At least 2 years’ experience as Lead Monitor, preferably in regional capacity
Experience supervising clinical project activities and leading clinical project teams
Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications is preferable
Communication, presentation, and customer-service skills
Team building, leadership, and organizational skills
Full working proficiency in English
Proficiency in MS Office applications, including MS Project

Benefits

Comp & perks

Stable and secure workplace
Professional development and investment in employee success
Inclusive culture where colleagues feel welcomed and valued
Remote work option