Clinical Trial Manager

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

📋 Description

• Oversee the integration of activities within the project team.

• Direct strategic study operations, which encompass study sites, regulatory submissions, drug supply and usage, subject enrollment, regulatory document management, study timelines, budgets, financial data, performance metrics, and data flow.

• Contribute to trial-level operational strategies from protocol design to the completion of the clinical study report.

• Provide insights into global subject and patient recruitment strategies.

• Manage the identification of CROs and vendors, along with daily operational tasks, including setup, creation of statements of work, and budget management.

• Develop and revise essential trial-specific documentation.

• Assist in creating training materials at the compound and protocol levels.

• Review and offer feedback on budgets, timelines, and forecasts for assigned clinical studies.

• Aid in trial-level inspection readiness efforts, including the identification of risks and the development of mitigation strategies.

• Engage in process improvement initiatives at both the trial and departmental levels.

• Foster relationships between study sites and vendors.

• Collaborate with internal key stakeholders.

• Assist in onboarding new team members.

• Participate in stakeholder meetings, providing operational updates and insights.

⛳️ Requirements

• A Bachelor's degree is mandatory.

• At least 5+ years of clinical research experience with a CRO, biotech, or pharmaceutical company focusing on Phase I–IV global clinical trials.

• 2–3 years of experience in leading components of global clinical trials.

• Familiarity with working alongside CROs.

• Strong decision-making, analytical, and financial management capabilities.

• Excellent leadership qualities and the ability to function with minimal supervision.

• Experience leading in multifunctional, matrixed, and global settings without direct authority.

• Background in mentoring and coaching colleagues.

• Outstanding organizational skills with the capacity to prioritize competing demands.

• Strong reasoning and problem-solving skills.

• Proficient project planning and management skills, along with strong written, verbal communication, and presentation abilities.

• Experience in the development and review of protocols, informed consent forms (ICF), case report forms (CRF), and clinical study reports (CSR).

• Proficiency in the MS Office Suite, including Excel, Word, and PowerPoint.

• Willingness to travel approximately 10% of the time.

🏝️ Benefits

• Flexibility to work remotely within the United States.

• Opportunity to play a role in the development of therapies that positively impact patients.