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Senior Manager of Clinical Operations

Senior Manager of Clinical Operations Senior Manager of Clinical Operations Offi

2019-10-09 2020
Barrington James Clinical
Position: Senior Manager Salary: Unspecified Type: Full Time Location: New York City, NY
Senior Manager of Clinical Operations
Office Based- Murray Hill, NJ
Overview: My client is an Oncology drug discovery and development company that is looking for a Senior Manager of
Clinical Operations. This person will come in to manage phase 3 of a current project from start-up to close-out.
The Company: Founded in 2011, my client is an Oncology drug discovery company that is working towards the treatment
of hematological cancers and solid tumors. They have raised $531 million since that time to advance their pipeline of
programs. They specialize in proprietary antibody drug conjugates.
The Senior Manager will be responsible for: The start-up and executions of multiple clinical trials from start to finish. This
will include oversight of all partners and vendors, budgets, timelines, status report, and risk and mitigation plans.
Coordinate all aspects of domestic and international clinical trials from start-up through close-out including;
Study Development
Project Management
Budgets and Timelines
Resource Requirements
Audit Readiness
Corrective Action Plans
Trial Risk
Operations
Collaborate with independent clinical advisors during the development of clinical protocols.
Lead study teams through the use of strong project management skills and cross functional team work
Recruit, negotiate compensation, manage deliverables, and provide feedback to consultants and contractors.
Manage site and investigator selection process.
Develop/ review clinical project deliverables such as;
Protocols and Amendments
Case Report Forms (CRFs)
Investigator Brochures
Informed Consent
Trial Manuals
Operation Plans and others
Work with data management to set up data capture system, capture ongoing data, and data review.
Manage clinical supply usage, enrollment of subjects, and regulatory document flow.
Provide oversight of clinical trials to insure safety and compliance
Required Experience
BS/BA in related field
4+ years of experience in clinical research
Knowledge of ICH and global clinical trails
Ability to manage multiple priorities across multiple trials
Experience with CRO and Vendor management
Experience leading cross functional studies and teams
Willingness to travel up to 20%
Oncology experience preferred
Excellent time management, planning, and prioritizing ability
Strong communication skills
Apply

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