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, approvals, and tracking.
- Ensure clinical and ancillary supplies -including import/export logistics and supply destruction processes- are in place as applicable.
- Manage operational aspects to support subject recruitment and retention, patient safety, vendor performance, and the monitoring visit strategy.
- Proactive planning for monitoring activities to ensure data integrity, patient safety and endpoint protection.
- Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management.
- Oversight and approval of site payments, including payment reconciliation.
- Foster effective communication and collaboration with clients and cross-functional project teams in a global and multicultural environment.
- Ability to lead client-facing calls to communicate project status updates and demonstrate operational control of start-up and clinical deliverables.
- Support new business with active participation in pre-award preparation as required.
- Provide feedback on team members as needed to respective line managers.
-
All other duties as needed or assigned.
Qualifications (Minimum Required)
- University/college degree (life science preferred) or certification in a related allied health profession (nursing, medical, or laboratory technology) from an appropriately accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Fluent in English, both written and verbal
Experience (Minimum Required)
- Four or more years of relevant clinical research experience in pharmaceutical, CRO, or health care setting will be considered.
- Comprehensive knowledge of GCP, ICH, and regulatory guidelines.
- Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms (e.g. Veeva Vault, Medidata).
- Effective leadership in remote and global environment.
- Strong communication, plan