Clinical Trial Manager

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For one of our clients, we are looking for a Clinical Trial Manager, remotely from the United States.

As a Clinical Trial Manager (CTM), you will be responsible for the successful planning, implementation, and execution of clinical trials. You will manage and lead clinical monitoring activities, ensuring effective communication with clients and internal teams. You will also be tasked with overseeing site management, monitoring, and regulatory compliance throughout the trial's lifecycle. Your role will be pivotal in ensuring that clinical trials run smoothly, meet regulatory standards, and achieve the goals of the study.

Accountabilities:

• Oversee all activities related to the implementation and execution of clinical studies.
• Develop and implement the Clinical Monitoring Plan and manage clinical site activities such as recruitment, selection, and regulatory document collection.
• Ensure timely site visits, monitor data trends, and proactively address issues in collaboration with the clinical monitoring team.
• Manage the coordination of clinical trial milestones and ensure adherence to project timelines and budgets.
• Mentor and train Clinical Research Associates (CRAs) and perform field assessments when required.
• Provide regular feedback on performance appraisals for CRAs and ensure adherence to Standard Operating Procedures (SOPs).

Requirements

• Bachelor's degree in life sciences or related field, with at least 5 years of experience in clinical studies.
• Minimum of 4 years as a Clinical Monitor or CRA, with at least 1 year of experience in a lead role.
• Thorough knowledge of clinical research processes and the ICH GCP guidelines.
• Strong organizational and interpersonal skills with the ability to manage multiple clinical trials.
• Proficiency in electronic data capture (EDC) systems and Microsoft Office Suite.
• Ability to mentor and support team members, with excellent verbal and written communication skills.
• Willingness to travel domestically and internationally as required.

Benefits

• Competitive salary and comprehensive benefits package.
• Flexible working arrangements with the option for remote work.
• Opportunities for career development and growth within a dynamic and supportive team environment.
• A collaborative and inclusive work culture that encourages work-life balance.
• Access to ongoing training and professional development programs.
• Health and wellness benefits, including medical and dental coverage.

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Qualification

Bachelor's Degree