Clinical Operations Manager/Sr. Clinical Operations Manager (Oncology Experience Required) - Scorpion Therapeutics

Job Summary:

In this important role within Clinical Operations, the manager/Sr. Manager is responsible for collaborating with clinical and regulatory functions to execute on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. The manager/Sr. Manager will work with the Clinical Study Lead to ensure on time delivery of key tasks within a clinical study. In addition to exceptional project delivery, we seek strong analytical skills, attention to detail, and leadership qualities that will influence our internal team and motivate our CRO partners. The ideal candidate values bringing important medicines to patients in need, and shares our team's determined, positive attitude.

Role Responsibilities/Accountabilities:

• Devise and implement efficient, effective clinical trial execution strategies; inform planning and monitor execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.
• Provide internal updates on trial progress to leadership with respect to project plans, timeline, budgets, quality standards, and regulatory compliance.
• In collaboration with the Clinical Study Lead, Program level clinical operations leadership, and CRO (if applicable), ensure procedures and support are available to facilitate delivery of high-quality clinical data.
• Ensure compliance of clinical trials with federal and applicable regulatory agency requirements.
• Facilitate expert review and manage the generation, approval, and control of trial documentation, including but not limited to invoices, protocol, and informed consent documentation.
• Successfully partner with and oversee the CRO and their conduct of the clinical study (if applicable).
• Facilitate data lock and transfer of data for analysis. Coordinate data analysis and reporting in an efficient and timely manner. Complete trial reporting compliant to regulatory requirements.
• Ensure all project level documentation is filed in accordance with SOPs/regulatory requirements including archiving and maintenance.

Background/Experience and Education:

• BS/MS in science or a health-related field is preferred.
• Preferably 4 or more years related work experience, with at least 2 years in a study management role. Biopharmaceutical (Sponsor) organization experience is a preferred.
• Demonstrated effectiveness in resolving study management issues.
• Experience managing a broad project team in a matrix setting is required; direct line management is not required.
• In-depth knowledge of the CRO management strategies is required.
• Strong communication, project management, and data analysis skills;
• Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
• Prior NDA/BLA submission experience is desirable.
• Prior experience in Oncology drug development and Phase 1 trial execution is desirable.
• Up to 30% travel may be required to research sites, investigator meetings or vendor meetings. International travel may be required.