Lead Clinical Research Associate

PSI CRO AG

. Oversee and guide the clinical team while driving trial activities at a country or regional level .

Posted 11/5/2026full-timeRemote • MalaysiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including oversight of site monitoring, compliance, and data integrity. Proficient in coordinating cross-functional teams and ensuring timely project execution while maintaining high-quality standards.

Highest-signal resume keywords

Clinical Trial ManagementSite Monitoring ExperienceOncology ExpertiseRegulatory Submission PreparationProject Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringData Integrity ManagementPatient EnrollmentCorrective Action and Preventive Action (CAPA)Study Risk ManagementSource Data VerificationMonitoring Visit CoordinationClinical Supply ManagementTraining DevelopmentAudit Preparation

Soft Skills

Excellent CommunicationCollaborationProblem-SolvingMultitaskingTeam Leadership

Tools & Technologies

MS Office ApplicationsTracking SystemsClinical Study Supplies Management

Industry Keywords

Life SciencesPhase II TrialsPhase III TrialsOncologyGastroenterologyInfectious DiseasesAutoimmune DiseasesRare Diseases

About the role

Key responsibilities & impact

Oversee and guide the clinical team while driving trial activities at a country or regional level
Ensure high-quality execution, compliance, and timely delivery
Coordinate across cross-functional teams
Monitor project timelines, patient enrollment, data cleaning, and compliance
Implement corrective and preventive measures
Review monitoring visit reports and ensure reporting compliance
Act as the main communication line between Monitors, Site Management Associates, Regional Project Leads, and Project Managers
Lead country-level project team calls and provide status updates and reports
Provide project-specific training and prepare training materials
Supervise source data verification and follow up on site-level data queries
Review and manage site-level study risks
Ensure proper handling, accountability, reconciliation, and return of investigational products and clinical study supplies
Review essential study documents and supervise reconciliation of ISF/TMF
Ensure site-level data integrity and compliance
Collaborate on investigator/site feasibility, identification, and study startup
Manage Monitors in query resolution, including Central Monitoring observations
Coordinate safety information flow and protocol/process deviation reporting
Manage clinical supplies with vendors at country and regional levels
Maintain study-specific and corporate tracking systems
Coordinate and conduct supervised monitoring visits
Manage site contracting and payments
Conduct audit preparation visits, participate in site audits, and coordinate resolution of audit findings
Oversee CAPA development and implementation
Coordinate process deviation review, management, and reporting
Conduct initial training and authorization monitoring visits for Monitors
Mentor newly promoted Lead CRAs
Deliver training and presentations at Investigator Meetings
Ensure subject recruitment targets and project timelines are defined, communicated, recorded, and met
Ensure timely information flow with trial sites on adverse events and protocol/process deviations
Supervise Site Management Associates in document and laboratory supply flow
Support preparation of regulatory and ethics committee submission packages

Requirements

What you’ll need

Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience
Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level
Experience with all types of monitoring visits in Phase II and/or III
Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable
Full working proficiency in English
Proficiency in MS Office applications
Ability to plan, multitask and work in a dynamic team environment
Excellent Communication, collaboration, and problem-solving skills
Ability to travel

Benefits

Comp & perks

Stable and secure workplace
Inclusive culture and welcoming environment
Career advancement opportunities
Opportunity to coordinate varied tasks and learn new things
Opportunity to grow with the company