Clinical Study Manager-Remote(Job Id- 3908-1)

The Study Specialist will augment activities performed by existing study team members whether from client or client’s preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: Oversight by client Clinical Operations Study Team Lead Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites Point of escalation for clinically identified site related issues Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality Supports inspection readiness including for example the facilitation of the collection an