Clinical Trial Manager III

This is a fully remote position, open to applicants in South Korea, +3 more countries.

📋 Description

• Take full responsibility for overseeing all start-up and clinical tasks from identifying sites to the lock of the database.

• Manage the project's scope, timelines, milestones, budget, quality, compliance, and commitments specific to each country.

• Identify and mitigate risks related to the project, finances, quality, and operations.

• Anticipate revenue, manage contracted scope, and supervise any modifications to the scope.

• Monitor Key Project Indicators and ensure precise resource projections.

• Develop strategies for site activation and recruitment.

• Lead the process of site identification and selection.

• Oversee the development and translation of informed consent forms.

• Manage the creation and collection of essential documents, including insurance paperwork.

• Supervise the development, negotiation, execution of Clinical Trial Agreements, and site budgets.

• Direct the submissions, approvals, and tracking for regulatory and ethics committees.

• Ensure the availability of clinical and ancillary supplies, import/export logistics, and processes for supply destruction.

• Oversee subject recruitment and retention, patient safety, vendor performance, and monitoring visit strategies.

• Plan monitoring activities to ensure data integrity, patient safety, and endpoint protection.

• Guarantee inspection readiness by managing TMF, monitoring reports, protocol deviations, and issue management.

• Supervise and approve site payments and their reconciliation.

• Promote communication and collaboration with clients and global cross-functional teams.

• Lead calls with clients and provide updates on project status and operational control.

• Assist in new business initiatives through pre-award preparation.

• Offer training and support to new and junior team members.

• Perform additional assigned duties.

⛳️ Requirements

• A university or college degree (preferably in life sciences) or certification in a related allied health profession (such as nursing, medical, or laboratory technology) from an accredited institution.

• Fortrea may accept relevant equivalent experience in place of educational qualifications.

• Proficient in English, both written and verbal.

• A minimum of five years of relevant clinical research experience in pharmaceutical, CRO, or healthcare settings.

• In-depth understanding of GCP, ICH, and regulatory guidelines.

• Competency in Microsoft Office.

• Familiarity with EDC, CTMS, eTMF, and vendor platforms like Veeva Vault and Medidata.

• Strong leadership capabilities in remote and global settings.

• Excellent communication, planning, and organizational skills.

• Proven ability to motivate teams.

• Skilled in managing multiple tasks in time-sensitive environments.

• Financial awareness and familiarity with tracking systems/tools.

• Demonstrated ability to independently solve problems and manage risks.

• Proven professional skills in client interaction and presentations.

• Capable of working both independently and collaboratively.

• Preferred: A Master’s degree or other advanced qualifications.

• Preferred: PMP certification or equivalent.

• Willingness to travel globally up to 20% of the time.

🏝️ Benefits

• Opportunity for remote-based work.

• Potential office presence based on location.

• Up to 20% global travel, primarily domestic and international.

• EEO & accommodations support.