Clinical Trial Manager (Study Startup)

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

Clinical Trial Manager (Study Startup)

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are looking for an experienced Clinical Trial Manager, Study Start-Up to lead and coordinate study start-up activities and drive clinical trials toward timely site activation.

In this role, you will oversee key start-up deliverables, including regulatory and ethics submissions, documentation, start-up payments and associated fees, and cross-functional coordination to ensure studies are ready to begin on time.

What You Will Do:

• Lead and coordinate end-to-end study start-up activities, from study handover through site activation.
• Develop and manage study start-up plans, timelines, milestones, and key 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 and sites.
• Manage and track study start-up payments and fees, including regulatory, ethics committee/IRB, and other applicable start-up costs.
• Coordinate payment requests, supporting documentation, approvals, and follow-up to help ensure start-up payments are processed within required timelines.
• Partner with Regulatory, Finance, Clinical Operations, Contracts, and other stakeholders to resolve payment-related issues that could impact study initiation or site activation.
• Monitor overall start-up progress and proactively identify and resolve risks, bottlenecks, and potential delays.
• Provide stakeholders with clear updates on start-up timelines, submissions, payments, approvals, risks, and site activation status.
• Ensure activities are conducted in accordance with applicable SOPs, ICH-GCP, and regulatory requirements.
• Contribute to process improvements that enhance the efficiency and quality of study start-up activities.
  

Your Profile:

• Bachelor’s degree in Life Sciences, Healthcare, or a related discipline.
• Strong experience in clinical research and study start-up, ideally within a CRO, biotech, or pharmaceutical environment.
• 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 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 with the ability to proactively drive activities to completion.
• Must be amenable to work in a hybrid setup (2-3x a week onsite in Makati)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.