Manages project-level operational aspects of the CTT including management of trial timeline, budget, resources and vendors.
Provide efficient updates on trial progress to the CMO or CPD with respect to vendor selection, project plans, study budget and timeline management, quality standards and risk mitigation.
Lead sponsor study startup process, including but not limited to conduct of Study Kick-off meeting, setup of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
Ensure effective project plans are in place and operational for each trial and work proactively with the CTT to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
Ensure potential study risks are escalated to the attention of the CMO or CPD when appropriate.
Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team.
Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner.
Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
Effectively provide support to Clinical Site Manager(s) in the conduct of the trials.