Clinical Trial Manager: Lead Study Operations & Compliance

OrciMed Life Sciences Philippines OPC; Metro Manila; On-site; PHP 1,200,000 - 1,800,000; Full time

Job summary

OrciMed Life Sciences Philippines OPC in Manila is seeking a Clinical Trial Manager to lead day-to-day clinical operations across CROs, sites, and vendors, ensuring on-time, compliant delivery of monitoring and study activities. You will collaborate with cross-functional teams to align expectations and manage risk while maintaining study integrity.

The role requires a nursing or life science background, 5+ years monitoring experience, strong knowledge of ICH GCP and CTMS/EDC systems, plus

Qualifications

• Bachelor's degree in nursing or life science, or equivalent.
• At least two years' CRO clinical trial management experience.
• Five or more years of monitoring experience.
• Extensive knowledge of ICH GCP and related guidelines.
• Experience with EDC and CTMS systems.
• Strong communication, organizational, and interpersonal skills.

Responsibilities

• Manage the quality and clinical operations of assigned studies while remaining ICH GCP compliant.
• Collaborate with the Project Manager to prepare, organize, and present investigator meetings.
• Deliver documents and study materials for the clinical department promptly.
• Generate the Clinical Monitoring Plan.
• Establish and maintain tracking tools for assigned trials and ensure maintenance of relevant sections of the Trial Master File and Project Status Reports.
• Perform reviews of monitoring visit reports and confirm alignment with the timeline.
• Proactively identify and resolve issues and participate in process improvement initiatives.
• Develop and track timelines, budget, quality, and performance metrics for clinical operational activities.
• Manage study investigators, study sites, clinical monitors, clinical field specialists, and any assigned vendors.
• Conduct regular meetings with the Clinical Research Associates, and actively participate in team meetings with functional leads to assess and mitigate emerging or potential risks.

Skills

Communication skills

Organizational skills

Interpersonal skills

Mentoring/training

Education

Bachelor's degree in nursing or life science

Tools

EDC systems

CTMS systems

Job description

OrciMed Life Sciences Philippines OPC in Manila is seeking a Clinical Trial Manager to lead day-to-day clinical operations across CROs, sites, and vendors, ensuring on-time, compliant delivery of monitoring and study activities. You will collaborate with cross-functional teams to align expectations and manage risk while maintaining study integrity.

The role requires a nursing or life science background, 5+ years monitoring experience, strong knowledge of ICH GCP and CTMS/EDC systems, plus