Position Summary

The Senior / Clinical Trial Manager is responsible for the operational management, oversight and execution of one or more clinical trials including CROs, vendors, and consultants as needed for the conduct of clinical studies. This individual will report to the Sr Director, Global Clinical Operations.

Responsibilities

• Provides full management of 1 or more studies within the portfolio of clinical trials
• Provides study leadership and effectively collaborates with other departments and functional groups to meet study timelines and corporate goals
• Independently creates and/or oversees the design of study related documents including but not limited to: clinical protocols, case report forms, study manuals and plans, informed consent forms, safety committee charters
• Manages study-specific CROs, vendors and contractors
• Reviews CRO and vendor scope of work / work orders
• Works closely with CROs to set up study systems, such as Safety management, data management, clinical monitoring, TMF, etc.
• Responsible for review and approval of IP release packages
• Management of the labeling and distribution requirements of the IP
• Works together with the Sr Director to develop and track study budgets and financial forecasting
• Prepares study updates and tracking information for departmental / company meetings
• Establishes and leads study management team meetings internally and via teleconferences with study vendors
• Prepares and presents study-specific slide presentations during Investigator Meetings. Leads training sessions for the training of CROs and field CRA’s
• Attends scientific meetings as a representative for the clinical operations team.
• Proactively identifies and communicates study-related issues and facilitates discussion of potential solutions that can be implemented by the team
• Exercises professional judgment in selecting methods and techniques for obtaining optimal results
• May participate in clinical research SOP development or updates as appropriate
• Uses well-developed problem-solving skills to address needs of program and provides leadership and guidance to other lower level personnel
• Attends site initiation visits, as applicable, as a representative of the study sponsor

Requirements

• BA / BS, RN or higher degree
• 8 years clinical operations experience, with 4 years of that in the CTM role or higher, in the pharmaceutical / biotech industry
• Experience with managing CTMs, CRAs and Clinical Assistants
• Experience with early phase trials, ophthalmology, immunology, and neurology is beneficial
• Experience working within a small biotech company preferred
• Working knowledge of GCP/ICH guidelines and the clinical development process