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