Lead of the Quality Control and Filing TeamProvide leadership and guidance to the quality control team, filing team, and TMF reconciliation task forces.Ensure TMF annual review requirements are in alignment with annual quality assurance expectations.Perform comprehensive file reviews on paper and eTMF for early and late phase studies across multiple indications.Create TMFs and maintain essential documents in compliance with FDA regulations, ICH / GCP guidelines and local laws.Mange ongoing collection and quality review of updated essential documents for submission to the TMF.Ensure a complete and compliant client TMF for audits and study deliverables.Site ManagerManage site relationships and ensure positive interactions through routine site contact.Evaluate sites to determine interest, adequate subject population, facilities, staff, and qualifications to conduct a study.Provide site training and access to required systems, including vendor systems.Track study activities, milestones, received documentation, and payment status in CTMS.Prepare, distribute, collect, evaluate and approve regulatory documents required for regulatory compliance.

Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites. • Utilizes the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked. • Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines. • Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements. • Performs study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete. • Documents site and Sponsor contact and study interactions in a timely and professional manner. • Assists with resolution of investigational site/data queries. • Liaises with project team members regarding study site issues. • Provides quality review of the informed consent template.

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.• Distribute completed documents to sites and internal project team members.• Prepare site regulatory documents, reviewing for completeness and accuracy.• Review, prepare and negotiate site contracts and budgets with sites.• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.• Review and provide feedback to management on site performance metrics.• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.• Inform team members of completion of regulatory and contractual documents for individual sites.• Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.• Provide local expertise to RSU leads and Project team during initial and ongoing project timelines planning.• Perform quality control of documents provided by sites.• Direct contact with sponsors on specific initiatives.• Perform Site Selection Visits if a trained monitor.• Participate in feasibility and/or site identification activities.