Clinical Trial Manager (China Nationwide)

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:

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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.

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Ensure start-up and clinical project plans address identified risks while adhering to professional standards, SOPs, client, and regulatory requirements.

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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.

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Responsible for financial aspects of clinical and start-up activities, including revenue forecasting, adherence to contracted scope, and oversight of scope modifications.

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Ensure project team awareness and tracking of Key Project Indicators (KPI) for any client-specific start-up and clinical metrics.

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Ensure and plans for start-up and clinical resources with accurate projections for the resourcing teams.

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Develop and implement the site activation and recruitment strategy in collaboration with project teams.

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Lead and oversee site identification and site selection.

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Oversight of Informed Consent Form development and translations.

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Oversight of essential document creation and collection, including insurance.

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Oversight of the development, negotiation, and execution of Clinical Trial Agreements (CTA), including site budgets.

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Lead the end-to-end process of regulatory/ethics committee submissions, approvals, and tracking.

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Ensure clinical and ancillary supplies -including import/export logistics and supply destruction processes- are in place as applicable.

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Manage operational aspects to support subject recruitment and retention, patient safety, vendor performance, and the monitoring visit strategy.

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Proactive planning for monitoring activities to ensure data integrity, patient safety and endpoint protection.

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Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management.

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Oversight and approval of site payments, including payment reconciliation.

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Foster effective communication and collaboration with clients and cross-functional project teams in a global and multicultural environment.

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Ability to lead client-facing calls to communicate project status updates and demonstrate operational control of start-up and clinical deliverables.

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Support new business with active participation in pre-award preparation as required.

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Provide feedback on team members as needed to respective line managers.

- All other duties as needed or assigned.

Qualifications (Minimum Required):

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University/college degree (life science preferred) or certification in a related allied health profession (nursing, medical, or laboratory technology) from an appropriately accredited institution.

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Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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Fluent in English, both written and verbal

Experience (Minimum Required):

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Four or more years of relevant clinical research experience in pharmaceutical, CRO, or health care setting will be considered.

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Comprehensive knowledge of GCP, ICH, and regulatory guidelines.

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Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms (e.g. Veeva Vault, Medidata).

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Effective leadership in remote and global environment.

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Strong c