Clinical Trial Manager (Study Startup)

ICON; Manila; Hybride; PHP 1 897 000 - 2 790 000; Plein temps

Résumé du poste

ICON Strategic Solutions is seeking an experienced Clinical Trial Manager, Study Start-Up to lead end-to-end study start-up activities and drive site activation across countries. You will oversee regulatory submissions, start-up documentation, and payment management in a cross-functional setup, with a hybrid work pattern (2–3 days onsite in Makati).

Strong project management, ICH-GCP knowledge, and excellent communication are essential.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience in CRO/pharma environments preferred.
• Experience across multiple sites/countries.
• Knowledge of regulatory submissions, essential documents, start-up payments/fees.
• Experience coordinating regulatory, ethics submissions and start-up payments.
• Strong project management, timelines, dependencies and stakeholders.
• Knowledge of ICH-GCP and clinical research regulations.
• Excellent communication and organizational skills; hybrid work in Makati (2–3x/wk).

Responsabilités

• Lead end-to-end study start-up activities and site activation.
• Develop study start-up plans, timelines and milestones.
• Coordinate country/site feasibility, selection and activation.
• Manage start-up documentation and tracking.
• Coordinate regulatory and ethics submissions and approvals.
• Oversee start-up payments and associated fees.
• Process payment requests with approvals and follow-up.
• Collaborate with Regulatory, Finance, Clinical Ops and Contracts.
• Monitor progress, identify risks and drive on-time initiation.
• Provide updates on timelines, submissions, payments and activation.

Connaissances

Study start-up

Regulatory submissions

Project management

Communication

Formation

Bachelor’s degree in Life Sciences or related

Description du poste

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)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here