Job: Sr. Manager Clinical Operations

Duties and Responsibilities:

• Responsible for representing Operations on cross-functional study teams and Vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
• Manages cross-functional study teams and vendor operational meetings to ensure compliance with  operational responsibilities
• Provide leadership for Operations related issues and advise management team of potential issues and solutions
• Manage, coach and develop junior staff in order to maximize their capability and contribution to provide high quality deliverables
• Responsible for the review and oversight of  responsibilities in study data management plans for  operations and operational responsibilities associated with all clinical trials
• Monitor global regulatory intelligence for global industry practices for operational efficiency and compliance
• Responsible for operational guidance for investigators and provide CRO training related to  the study conduct
• Responsible for managing  queries for clinical studies from CROs
• Participate in the conduct of Audits and Inspections related to Operations
• Address consistency in collection, processing and evaluation of clinical data, contribute to the development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in global processes
• Represent Clinical Operations on global teams as an operation owner and/or function as a vendor relationship manager for vendors
• Support clinical trials and development programs

Education:

Bachelor’s required in a scientific/medical field.  Advanced degree preferred.