Clinical Trial Manager-Consultant

YOU WILL BE RESPONSIBLE FOR:

• Supporting end-to-end clinical trial execution, ensuring delivery against timelines, quality standards, and budget
• Assisting in start-up activities of clinical research studies including Investigator site selection
• Contributing to development of clinical protocols and study documents including informed consent forms, study logs, study manuals, study plans, case report forms and guidelines
• Assisting in development of training materials and training of CRAs and other CRO personnel
• Attending co-monitoring and/or training visits at clinical sites as required
• Attending and co-monitoring studies (PSV, SIV, IMV, COV) as needed
• Managing investigational product accountability and reconciliation processes
• Reviewing site and patient activity tracking data, preparing study updates and enrollment metrics and proactively identifying and resolving study-related issues
• Overseeing performance of CROs, third-party vendors and CRAs to ensure compliance with study protocol and scope, identifying concerns and escalating to the Clinical Team
• Reviewing Monitoring Visit Reports and escalating findings to the Clinical Team
• Guiding investigative site activities across multiple clinical trial sites, including but not limited to, SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability
• Ensuring site compliance with GCP and federal and applicable local regulatory requirements
• Developing and maintaining excellent working relationships with investigators and study staff
• Conducting all work in accordance with Milestone SOPs, ICH GCP guidelines, and applicable regulations, and practices continuous improvement

Qualifications:

• Bachelor’s degree or equivalent with a minimum of two-years’ experience in clinical development and operations, including experience monitoring at clinical sites
• PREFERRED: Experience from a pharma sponsor or CRO
• MUST HAVE: Thorough understanding of GCP and ICH regulations, clinical trial monitoring and regulatory compliance
• Demonstrated effectiveness in resolving site management issues of varying complexity
• A resourceful, confident professional with strong communication and interpersonal/team skills
• Strong initiative and can-do attitude, with the ability to prioritize and multitask effectively
• Demonstrated ability to identify and resolve issues and effectively manage timelines