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 B.Forsen@proclinical.com.
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.
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