Clinical Trial Start-Up Lead | Hybrid (Makati)

KCR Placement; Manila; Hybrid; PHP 1,897,000 - 2,790,000; Full time

Job summary

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).

Responsibilities

• 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.

Skills

Study start-up

Regulatory submissions

Project management

Communication

Education

Bachelor’s degree in Life Sciences or related

Job description

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.