Clinical Trial Manager Position Available In Wake, North Carolina

Job Title:

Clinical Trial Manager Job Description The Clinical Trial Manager is responsible for managing clinical trial studies within specific therapeutic areas. The role involves providing guidance and oversight to project teams for successful study operations, adhering to GCP/ICH Guidelines, regulatory requirements, company SOPs, and study protocols. Responsibilities Oversee third-party vendors and coordinate responses to audits. Evaluate vendor performance and implement corrective action plans. Provide clinical input and develop necessary clinical documents for regulatory submissions. Manage the planning and execution of investigator meetings. Develop study-specific timelines and coordinate with program timelines. Ensure internal functional areas complete deliverables and manage study issues. Communicate study information effectively to various departments. Identify risks and opportunities in clinical studies and develop mitigation plans. Collaborate with Biometry to develop case report forms and data management plans. Coordinate with the Manager of Supplies for timely manufacturing and shipping of supplies. Work closely with the Manager of Contracts on study budgets and vendor selection. Lead meetings with CROs, vendors, and multi-functional teams to ensure quality and timely deliverables. Review site and vendor invoices to ensure alignment with project expenses. Conduct training for internal staff, CRO staff, vendors, investigators, and study coordinators. Essential Skills Experience in clinical trial management and ICH GCP guidelines. Oncology, Ophthalmology, and/or Biologics experience. Recent project management experience supporting sponsors and CROs. Strong vendor management skills. Additional Skills & Qualifications Proficiency in CTMS tracking systems. Ability to develop robust data management plans and ensure data integrity.