Clinical Trial Manager/ Senior Manager

Edgewise is headquartered in Boulder, Colorado and this is an on-site (preferred) or remote position for a growing Clinical Operations team. The assigned clinical studies will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to lead/provide oversight for more than one study or across programs and be assigned direct report(s).

Essential Job Duties and Functions:

• Provide operational expertise and strategic input for assigned clinical studies.
• Development and management of the study budget inclusive of site payment management and vendor invoicing.
• Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy.
• Provide strategic input and management of site activation activities and recruitment strategies.
• Oversight of study timelines to ensure the needs of the clinical development plan are met.
• Participate in vendor evaluation and selection activities. In conjunction with Research & Development QA support site and/or vendor audits including resolution of findings. Assigned Department Representative responsible for Clinical Vendor relationship and management as applicable.
• Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to management and/or governance committees when warranted.
• Oversight/execution of site selection and start-up activities as needed for assigned clinical studies (e.g. essential document review, Site Qualification Visit (SQV) and Site Initiation Visit (SIV) deck creation/review, participate in SQV/SIV, collaborate with contracts team to ensure timely execution of CTAs and Amendments as applicable)
• Oversight of Edgewise CRAs assigned to clinical studies as applicable. Oversight/Approval of  monitoring documents/plans and activities, including periodic review of outputs and actions related to monitoring. Perform or attend monitoring visits as needed for Sponsor representation.
• Development, review and approval of relevant study plans, as applicable.
• Study team meeting management and attendance; regular review of meeting agendas and minutes.
• Oversight of protocol deviation process for assigned study including review of individual protocol deviations, categorization and actions; primary purpose of review is to help identify trends across sites or the study.
• Review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.
• In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR. Participate in electronic data capture (EDC) system UAT. Proactively review EDC to identify issues. Participate in data review and assist internal/external team members with data-related queries/requests.
• Participate in the development of IRT systems through reviewing system specifications and UAT in collaboration with Clinical Supply and Statistics.
• Oversight and support of TMF activities as required.
• Participate in monthly Safety and Compliance meetings by reviewing adverse events, drug accountability and protocol deviations.
• Contribute to drafting Standard Operating Procedures (SOPs) and adhere to department and study-specific processes to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
• Support onboarding, mentor and manage direct reports within the department.
• May collaborate with other functional leads to manage project related efforts. Participate in departmental quality or process improvement initiatives.
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.