Clinical Trial Manager Ii (Madrid)

Clinical Trial Manager Ii (Madrid)

15 ago
|
Fortrea
|
Madrid

15 ago

Fortrea

Madrid

Job Overview:
The Clinical Trial Manager I has ownership in the clinical delivery and operational oversight of clinical research trials. This role collaborates with project managers and other functional leads to deliver clinical and start-up activities within budget and contract, ensuring quality, compliance and meeting country-specific commitments.

The role generally works under the direction of a (Senior) Clinical Trial Manager, however, may also work independently at a lower complexity study.

Summary of Responsibilities:
- End-to-end oversight of start-up and clinical responsibilities—from site identification through to database lock—through proactive management of project scope, timelines, milestones, and budget.
- Ensure start-up and clinical project plans address identified risks while adhering to professional standards, SOPs, client, and regulatory requirements.- Responsible for financial aspects of clinical and start-up activities, including revenue forecasting, adherence to contracted scope, and oversight of scope modifications.




- Ensure project team awareness and tracking of Key Project Indicators (KPI) for any client-specific start-up and clinical metrics.
- Ensure and plans for start-up and clinical resources with accurate projections for the resourcing teams.
- Develop and implement the site activation and recruitment strategy in collaboration with project teams.
- Lead and oversee site identification and site selection.
- Oversight of Informed Consent Form development and translations.
- Oversight of essential document creation and collection, including insurance.
- Oversight of the development, negotiation, and execution of Clinical Trial Agreements (CTA), including site budgets.
- Lead the end-to-end process of regulatory/ethics committee submissions, approvals, and tracking.
- Ensure clinical and ancillary supplies -including import/export logistics and supply destruction processes
- are in place as applicable.- Proactive planning for monitoring a

📌 Clinical Trial Manager Ii (Madrid)
🏢 Fortrea
📍 Madrid

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