# Clinical Trial Manager (Study Startup) **Company**: ICON Strategic Solutions **Location**: Manila, Philippines **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Philippines-Manila/Clinical-Trial-Manager--Study-Startup-_JR163149-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_1dfa9f33-0c2 ## Description 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. **Responsibilities:** - 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). **Rewards & Benefits** - 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 ## Skills ### Required - ICH-GCP - clinical research - study start-up - regulatory submissions - project management --- Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Philippines-Manila/Clinical-Trial-Manager--Study-Startup-_JR163149-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)