Clinical Operations Leader

Clinical Operations Leader - Contract - North Carolina, US

Proclinical is seeking a dedicated Contract Clinical Operations Lead to join the team in the Vaccines and Infectious Disease sector.

Primary Responsibilities :

The successful candidate will be responsible for overseeing clinical study operations, ensuring effective communication with stakeholders, and managing project timelines and resources.

This position requires a proactive approach to problem-solving and a commitment to maintaining high-quality standards.

Skills & 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.

The Clinical Operations Leader's responsibilities will be :

• Communicate effectively with internal and external customers and third-party vendors.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at [email protected].

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC