Clinical Operations Leader

Highly Competitive
  1. Contract
  2. VP/Head of Clinical Operations
  3. United States
North Carolina, USA
Posting date: 16 Oct 2024
62735

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.

INDSCIC

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