Job Description
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. Proactively identify and address start-up and clinical project, financial, and quality risks by applying comprehensive risk management strategies and ensuring compliance, including tracking within applicable systems. 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, approv
