[Hiring] Clinical Trial Manager III @Fortrea

Role Description

The Clinical Trial Manager II owns the clinical delivery and operational oversight of clinical research trials within the core project team. The CTM II 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. While the role may occasionally support larger, more complex trials under the guidance of a Senior Clinical Trial Manager, it is generally expected to manage most studies independently and comprehensively.

Summary of Responsibilities

• End-to-end oversight of start-up and clinical responsibilities—from site identification through to database lock.
• 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.
• Responsible for financial aspects of clinical and start-up activities, including revenue forecasting and oversight of scope modifications.
• Ensure project team awareness and tracking of Key Project Indicators (KPI) for any client-specific metrics.
• 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 are in place as applicable.
• Manage operational aspects to support subject recruitment and retention, patient safety, vendor performance, and 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.
• Ability to lead client-facing calls to communicate project status updates.
• Support new business with active participation in pre-award preparation as required.
• Provides training and support to new and/or junior team members.
• All other duties as needed or assigned.

Qualifications

• University/college degree (life science preferred) or certification in a related allied health profession.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Requirements

• Five or more years of relevant clinical research experience in pharmaceutical, CRO, or health care setting.
• Comprehensive knowledge of GCP, ICH, and regulatory guidelines.
• Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms.
• 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.

Preferred Qualifications Include

• Master’s or other advanced degree.
• PMP certification or equivalent.

Physical Demands / Work Environment

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