Senior Clinical Trial Manager
1 month ago
The Senior Clinical Trial Manager / Associate Director, Clinical Operations (Ophthalmology) 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 Executive Director, Clinical Operations.
Responsibilities
- Manages one or more studies within the Annexon portfolio of clinical trials
- Collaborates with other departments and functional groups to meet study timelines and corporate goals
- Creates and/or oversees the design of study related documents
- Manages study-specific CROs, vendors, and contractors
- Reviews CRO and vendor scope of work
- Works closely with CROs to set up study systems
- Responsible for review and approval of IP release packages
- Develops and tracks study budgets and financial forecasting
- Prepares study updates and tracking information for meetings
- Leads study management team meetings
- Prepares and presents study-specific slide presentations
- Attends scientific meetings as a representative of Annexon
- Proactively identifies and communicates study-related issues
- May participate in clinical research SOP development
- Addresses needs of program and provides leadership
- Attends site initiation visits as a representative of the study sponsor
- Experience managing clinical studies in ophthalmology drug development
- BA / BS, RN or higher degree
- 8+ years clinical operations experience
- Experience with managing CTMs, CRAs and Clinical Assistants
- Experience with early phase trials, immunology, and neurology is beneficial
- Working knowledge of GCP/ICH guidelines
- Diversity, Equity, Inclusion, and Belonging are important
- Friendly workplace with flexible work schedules and remote opportunities
- Competitive salary, equity participation, and comprehensive health benefits package
Annexon Biosciences is a clinical-stage biopharmaceutical company focused on bringing innovative medicines to patients with complement-mediated diseases. The company is advancing a pipeline of product candidates targeting various diseases of the body, brain, and eye. Annexon values Diversity, Equity, Inclusion, and Belonging in the workplace.
EEO Employer - Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer that promotes a work environment where everyone can do their best work.
Staffing Agencies
Annexon Biosciences does not accept unsolicited agency resumes. Inquiries must be sent through specific channels.
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