Clinical Trial Manager I- Oncology, FSP

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 or Clinical Trial Manager III.

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, with support.
• Ensure and plans for start-up and clinical resources with accurate projections for the resourcing teams.
• Develop, with oversight, 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

• 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

• Two to three years of relevant clinical research experience in pharmaceutical, CRO, or health care setting will be considered.
• 1 year of CTM or Lead CRA experience
• CRA experience (onsite monitoring)
• 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.
• Proven team motivational skills.
• Proficiency in balancing concurrent tasks within time-sensitive environments.
• Financial awareness and use of tracking systems/tools.
• Demonstrated independent problem-solving and risk management mindset.
• Demonstrated professional client interaction and presentation skills, with ability to work independently and collaboratively.

Preferred Qualifications

• PMP certification or equivalent.

Pay

$130,000 - 135,000 USD annually

Schedule

Remote-based work required with possible office presence depending on location. Travel requirements: up to 20% (global – primarily domestic and international)