Clinical Trial Start-Up Lead — Hybrid (Makati)

Concrete Masters, Inc.; Manila; Hybrid; PHP 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health and wellbeing programmes

Learning and development opportunities

Competitive total rewards package

Job summary

ICON Strategic Solutions in Manila, Philippines, is seeking a Clinical Trial Manager (Study Start-Up) to lead end-to-end start-up activities and drive site activation across countries. The role emphasizes regulatory/ethics submissions, start-up payments, and cross-functional coordination to ensure trials commence on schedule.

The ideal candidate has a life sciences degree with CRO/pharma start-up experience, strong project management, and solid knowledge of ICH-GCP.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or a related discipline.
• Strong experience in clinical research and study start-up, ideally within CRO/biotech/pharma.
• Experience managing start-up activities across multiple sites or countries.
• Good understanding of regulatory and ethics submissions, essential documents, start-up payments/fees, and site activation processes.
• Experience coordinating regulatory, ethics committee/IRB, and other study start-up payment requirements.
• Strong project management skills with the ability to manage multiple timelines, dependencies, and stakeholders.
• Good knowledge of ICH-GCP and applicable clinical research regulations.
• Strong communication, organizational, and problem-solving skills to drive activities to completion.
• Must be amenable to work in a hybrid setup (2-3x a week onsite in Makati)

Responsibilities

• Lead and coordinate end-to-end study start-up activities, from handover to site activation.
• Develop and manage study start-up plans, timelines, milestones, and deliverables.
• Coordinate country and site feasibility, site selection, and activation activities.
• Drive preparation, collection, review, and tracking of essential start-up documentation.
• Coordinate regulatory and ethics submissions, approvals, and start-up requirements across countries/sites.
• Manage and track study start-up payments and fees (regulatory, ethics, other costs).
• Coordinate payment requests, approvals, and follow-up to ensure timely processing.
• Partner with Regulatory, Finance, Clinical Ops, Contracts, and others to resolve payment issues.
• Monitor start-up progress and proactively identify risks, bottlenecks, delays.
• Provide stakeholders updates on start-up timelines, submissions, payments, approvals, risks, site activation.
• Ensure activities follow SOPs, ICH-GCP, and regulatory requirements.
• Contribute to process improvements to enhance start-up efficiency and quality.

Skills

Study start-up

Regulatory submissions

Ethics submissions

Project management

Cross-functional coordination

Education

Bachelor's degree in Life Sciences

Tools

IRB/IRB submission systems

Job description

ICON Strategic Solutions in Manila, Philippines, is seeking a Clinical Trial Manager (Study Start-Up) to lead end-to-end start-up activities and drive site activation across countries. The role emphasizes regulatory/ethics submissions, start-up payments, and cross-functional coordination to ensure trials commence on schedule.

The ideal candidate has a life sciences degree with CRO/pharma start-up experience, strong project management, and solid knowledge of ICH-GCP.