Clinical Trial Manager

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

About the role

The Clinical Trial Manager (CTM) will work collaboratively across cross-functional teams with Project Management, Clinical Operations, Data Management, Medical Monitoring, Pharmacovigilance, and Regulatory Affairs while understanding and managing client expectations. The Clinical Trial Manager is responsible for the day-to-day management of clinical aspects of projects, including communication and interaction with clinical sites, CRAs, and third-party vendors. This position ensures the on-time and high-quality delivery of project-specific on-site and remote monitoring; accountability of clinical monitoring compliance, tracking of critical project tasks; strategic study enrollment support including project-specific enrollment planning and clinical team accountability. This role will be responsible for the identification, resolution/mitigation, and escalation of risks related to site management and monitoring of the trial.

Key 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

About you

• Bachelor's degree or its international equivalent, preferably in nursing or life science. In lieu of a degree, an equivalent combination of education and relevant work experience is required
• At least two (2) years of experience managing clinical trials within a CRO
• Five (5) or more years of monitoring experience required or relevant experience in lieu
• Extensive knowledge of relevant international regulations and guidelines, ICH GCP, and other relevant GCP guidelines for clinical trial management
• Prior experience in electronic data capture (EDC) and electronic clinical trial management (CTMS) systems is required
• Strong knowledge of clinical trial processes
• Knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management
• Strong communication skills (verbal and written) to express complex ideas
• Excellent organizational and interpersonal skills
• Ability to mentor and train clinical staff