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.
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.
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.
Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations and issue management.
Foster effective communication and collaboration with clients and cross-functional project teams in a global and multicultural environment.
Support new business with active participation in pre-award preparation as required.
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.
Requirements
Ability to lead client-facing calls to communicate project status updates and demonstrate operational control of start-up and clinical deliverables.
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.
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. Previous SSU and Clinical Trial Lead
experience 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).
Proficiency in balancing concurrent tasks within time-sensitive environments.
Demonstrated professional client interaction and presentation skills, with ability to work independently and collaboratively.
requirements and internal training, without altering the fundamental nature or classification of the position. Preferred
Qualifications Include: Master’s or other advanced degree.
PMP certification or equivalent.
Experience
Fortrea is seeking Clinical Trial Managers to join our team! We are seeking experienced CTLs with 3+ years of experience. .
Benefits
Oversight of essential document creation and collection, including insurance.
requirements: up to 20% (global – primarily domestic and international) Pay Range: $140,000-148,000 USD annually Learn more about our EEO & Accommodations request here .
Additional details
Job Overview: The Clinical Trial Manager 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
Responsible for financial aspects of clinical and start-up activities, including revenue forecasting, adherence to contracted scope, and oversight of scope modifications.
Oversight of Informed Consent Form development and translations.
Oversight of the development, negotiation, and execution of Clinical Trial Agreements (CTA), including site budgets.
Proactive planning for monitoring activities to ensure data integrity, patient safety and endpoint protection.
Oversight and approval of site payments, including payment reconciliation.
Provide feedback on team members as needed to respective line managers.
Effective leadership in remote and global environment.