Clinical Trial Manager II

**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, planning, and organizational abilities…