Clinical Trial Manager

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

Preferred

life science

Master's or other advanced degree

PMP certification or equivalent

Benefits

Remote-based work

Internal training

Global clinical research organization providing clinical development solutions.

Durham, North Carolina, USA

https://www.fortrea.com

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Management and Executive

Engineering and Development

Customer Service and Support

Sales

Legal and Compliance

Trends of Total Sponsorships

*2026

(21)

2025

(14)

2024

(25)

2023

(6)

Late Stage

Leadership Team

Anshul Thakral

Chief Executive Officer

Agnieszka Gallagher

General Counsel, Chief Compliance Officer and Corporate Secretary

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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

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)

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

Life science

Master's or other advanced degree

PMP certification or equivalent

Four or more years of relevant clinical research experience in pharmaceutical, CRO, or health care setting will be considered.

Required skills

Clinical Research, Site Start-Up (SSU), Clinical Trial Leadership, Clinical Practice (GCP), ICH Guidelines, Regulatory Guidelines, Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), Veeva Vault, Medidata, Microsoft Office, PMP

Preferred skills

life science, Master's or other advanced degree, PMP certification or equivalent

Experience

4+ years