Sr Staffing Consultant II at Beacon Hill Staffing Group
REMOTE Senior Clinical Study Manager needed for Ophthalmology!
The Senior Clinical Trial Manager (Ophthalmology) will be 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 Executive Director, Clinical Operations.
Responsibilities
Provides full management of 1 or more studies
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 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 of 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
Experience managing clinical studies with experience in ophthalmology drug development.
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
Experience working within a small biotech company preferred
Working knowledge of GCP/ICH guidelines and the clinical development process
Seniority level
Director
Employment type
Full-time
Job function
Research and Project Management
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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