Clinical Trials Manager

Riboscience is seeking a passionate, creative, and dedicated individual to join our team as a Clinical Trial Manager (CTM) who will be responsible for supporting the day-to-day management of one or more clinical trials in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements, under the oversight of the Clinical Operations management. The CTM will help to drive completion of some specific study deliverables while ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required. Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, under the oversight of the study Senior CTM or Clinical Operations senior management. Manage aspects of one or more studies, including study metrics, study document development and review, plans and manages study-specific meetings, as appropriate. Contribute to and coordinate the review, as appropriate, of relevant documents including protocols, informed consent forms, case report forms, study plans, investigator brochures and clinical study reports. Help to coordinate the review of data listings with internal cross-functional stakeholders. May be asked to train investigators and study coordinators on operational study requirements. Perform vendor selection and set up (including scope of work review), may include central labs, imaging vendors, specialty labs and other vendors. Perform vendor oversight including effectively communicating expectations to vendors, ensure appropriate site management, hold vendors accountable to timelines, and verify quality metrics. Provide guidance, direction, and management to CRAs. Monitor the performance of clinical sites. Identify potential risks to study timelines and/or conduct, propose mitigations and implement mitigations with cross-functional team members and Clinical Operations management input. Establish and maintain strong relationships and communication with sites and site staff. Review site reports and assist in coordination of data management activities. Provide oversight of the Trial Master File (TMF) maintenance. Mentor and manage Clinical Trial Associates. Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies. Strong clinical study management skills. Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team building skills. Ability to work in a fast-paced start-up environment with demonstrated capacity to manage multiple competing tasks and priorities.