Hybrid Clinical Trial Start-Up Manager

ICON Clinical Research; Manila; Hybrid; PHP 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Health insurance

Leave entitlements

Retirement planning

Employee assistance program

Job summary

ICON Clinical Research in Manila is seeking a Clinical Trial Manager, Study Start-Up to lead end-to-end study start-up activities across multiple sites and countries, driving timely site activation.

You will oversee regulatory and ethics submissions, start-up documentation, and payments, coordinating with Regulatory, Finance, Clinical Operations, Contracts and other stakeholders to resolve issues and keep trials on schedule.

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 and/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 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.
• 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 start-up documentation.
• Coordinate regulatory submissions, approvals, and start-up requirements across countries/sites.
• Manage and track study start-up payments/fees.
• Coordinate payment requests, documentation, approvals, and follow-up to ensure timely processing.
• Partner with Regulatory, Finance, CRO, Contracts and other stakeholders to resolve payment-related issues.
• Monitor start-up progress and identify risks, bottlenecks, delays; provide status updates.
• Ensure activities comply with SOPs, ICH-GCP, and regulatory requirements.

Skills

Clinical trial management

Study start-up

Regulatory submissions

Budget/payments

ICH-GCP

Project management

Stakeholder management

Education

Bachelor's degree in Life Sciences

Job description

ICON Clinical Research in Manila is seeking a Clinical Trial Manager, Study Start-Up to lead end-to-end study start-up activities across multiple sites and countries, driving timely site activation.

You will oversee regulatory and ethics submissions, start-up documentation, and payments, coordinating with Regulatory, Finance, Clinical Operations, Contracts and other stakeholders to resolve issues and keep trials on schedule.