Clinical Operations Leader

Proclinical Staffing

Full-time - Mid Level

About the position

The Clinical Operations Leader is a contract position focused on overseeing clinical study operations within the Vaccines and Infectious Disease sector. This role involves ensuring effective communication with stakeholders, managing project timelines and resources, and maintaining high-quality standards throughout the clinical study process.

Responsibilities

• Oversee clinical study operations and ensure effective communication with stakeholders.
• Manage study start-up activities and provide input to project tools and plans.
• Develop and oversee site selection and monitoring plans.
• Review and contribute to patient recruitment and retention plans.
• Ensure team members have access to necessary tools and documents.
• Establish efficient working relationships with functional leaders and coordinators.
• Provide leadership and direction to project team members.
• Identify and deliver study-specific training.
• Monitor resource use and provide productivity targets.
• Address and resolve site issues, and develop contingency plans.
• Monitor study timelines, patient recruitment, retention, and data cleaning.
• Oversee maintenance and quality checks of Central Files.
• Ensure quality of work and follow up on escalated issues.
• Implement process improvements within the project.
• Provide input to the Revenue Recognition forecast and identify scope changes.
• Conduct site visits as required.
• Participate in client, investigator, and team meetings.
• Prepare for and follow up on audits and inspections.
• Collaborate on database lock activities and ensure administrative closeout procedures are completed.
• Participate in end-of-study meetings and contribute to lessons learned.

Requirements

• Strong communication and organizational skills.
• Experience in managing clinical study start-up activities.
• Ability to develop and oversee site selection and monitoring plans.
• Proficiency in developing patient recruitment and retention plans.
• Leadership skills to guide and support project team members.
• Problem-solving skills and ability to develop contingency plans.
• Experience in monitoring study timelines and ensuring project success.
• Attention to detail and commitment to maintaining high-quality standards.
• Ability to implement process improvements and manage project closeout activities.