Clinical Operations Manager Lead Role
This is an onsite position where the Manager Clinical Study Lead oversees the global execution of assigned clinical trials from study design through execution to study close out.
Key Responsibilities
* Accountable for study timelines and compliance with regulatory standards and procedures
* Leads cross-functional study teams providing operational input into protocol development
* Oversees setup and maintenance of study systems including CTMS and TMF
* Ensures compliance with clinical trial registry requirements
* Identifies outsourcing needs and leads vendor engagement contracting and management
* Provides input into baseline budget and timeline development
* Leads risk assessment and mitigation strategies
The ideal candidate will have:
* Demonstrated leadership and interpersonal skills
* Data-driven approach to planning and problem-solving
* Effective communication and project management skills
* Budget management experience and knowledge of industry trends
* Technical proficiency in trial management systems and MS applications
To be considered qualified for this role a minimum of a Bachelor's degree and 6+ years of direct clinical trial experience are required Direct experience managing global clinical trial operations and prior sponsor experience are highly preferred.