Biorasi

Clinical Research

• Manages or support all clinical aspects of a study, including assessing operational feasibility; assist in managing Clinical study timelines and metrics; provides study-specific training and leadership to clinical team; prepares and presents project debriefings, as required; plan, execute, lead or support study-specific meetings (e.g., Study Management Meetings, investigator meetings). Responsible for ensuring that Clinical Team delivers timely and high-quality project
• Site Management: Track and manage subject recruitment at all study sites. Oversee or supports the management of study Monitoring Visits, and review and approval of Monitoring Reports. Monitor study/site performance on an ongoing basis and escalate any infringements, breaches, and misconduct, fraud and trends at sites. Ongoing protocol deviation tracking, reporting, and trending. Notify sites of updates on global study information and updates.
• Study Start-Up: Uses operational and therapeutic expertise to optimize trial execution. Determine or contribute to the list of approved sites for selection visits. Plan or assist in allocating clinical team resources. Determine, develop and implement tracking and reporting specifications. Works with the study team to design clinical protocol; provides input for the design of the ICF template, source documents worksheets, and CRFs. Prepares and/or reviews study-related documents to include, visit report templates and annotations, clinical logs, forms, manuals and guidelines.
• Document and Supplies Management: Oversee or support the collection, review and filing of site essential documents, and maintenance of the TMF. Coordination of IP and clinical study supplies and oversee or support the overall tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC, CTMS, or vendor-specific
• Compliances: Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies. Participates in the planning of quality assurance activities and coordinates or support the resolution of audit findings.
• Staff Management: Support Clinical Management Team or act as functional Manager to Clinical operations staff allocated on assigned projects. Provides coaching and guidance to junior Clinical staff.
• Daily interaction with the Clinical Management Team and members of the cross-functional study team.
• Support study management team in selecting sites and countries; develops relationships with investigators and site staff.
• Support the cross-functional study team as needed; frequent cross-functional interactions with internal and external personnel (e.g., regulatory affairs, investigators, vendors, etc.).
• Lead or partake in regular team meeting / teleconferences; Participate/present at Client Presentation Meetings as necessary; Participate/present at Investigator Meetings as necessary.
• Communicate any out of scope issues to the Senior Clinical Management Team or Project Management Team as soon as identified.
• Other duties as assigned.

Clinical Trial Manager