Clinical Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Contributes to formulating clinical strategies that align with regulatory and commercial objectives.

• Collaborates with R&D, Regulatory, and Marketing teams on the design and endpoints of clinical trials.

• Prepares and delivers presentations of study findings to both internal and external stakeholders.

• Takes the lead in managing and executing assigned clinical studies.

• Oversees the development of protocols, site selection, budgeting, contracting, and management of CROs/vendors for the assigned studies.

• Ensures compliance with timelines, budgets, and enrollment goals.

• Manages resources and maintains the quality of clinical projects.

• Ensures that all clinical activities for the assigned studies comply with FDA, ISO, and ICH-GCP regulations.

• Prepares and reviews essential study documents, including protocols, informed consent forms, monitoring plans, and clinical study reports.

• Acts as a liaison with the Director of Clinical Research to oversee the monitoring activities, reports, and timelines of Clinical Research Associates.

• Identifies potential study risks and proactively implements strategies to mitigate them.

• Leverages available hardware and software to facilitate effective data review and capture for the clinical project.

⛳️ Requirements

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or a related field.

• 5–8 years of experience in clinical research, including at least 3 years in a managerial or leadership position.

• Strong understanding of FDA regulations, ISO 14155, and ICH-GCP standards.

• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).

• Familiarity with collaborating with CROs and clinical trial vendors.

• Full working proficiency in English.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development