We are seeking an experienced Senior Manager, Study Start Up to lead the global study start-up activities for clinical trials. This role requires a strong understanding of regulatory requirements and clinical trial processes.
Job Description
The successful candidate will oversee the study start-up process, including site identification, feasibility, regulatory document submission, and site activation across global clinical trials. They will collaborate with cross-functional teams to ensure alignment on study start-up strategies and objectives.
Key Responsibilities
* Lead and manage the study start-up process, ensuring timely completion and compliance with regulatory requirements
* Collaborate with clinical operations, project management, regulatory, and site management teams to drive efficiency in the clinical trial start-up process
* Monitor key performance indicators (KPIs) related to study start-up timelines and implement process improvements as needed
Required Skills and Qualifications
To be considered for this role, you will need:
* A bachelor's degree in life sciences, clinical research, or a related field
* Advanced degree or certification in project management or clinical operations is a plus
* Extensive experience in study start-up or clinical operations, with a strong understanding of global regulatory requirements and clinical trial processes
* Proven leadership and team management experience, with the ability to manage large, cross-functional teams in a fast-paced environment
* Excellent project management skills, with experience managing timelines, budgets, and resources for clinical trial start-up activities
Benefits
We offer a range of benefits to support your well-being and work-life balance, including:
* Flexible work arrangements
* Competitive salary and bonus structure
* Comprehensive health insurance
* Retirement savings plan
* Employee assistance program
About Us
We are a world-leading healthcare intelligence and clinical research organization, dedicated to fostering an inclusive environment that rewards high performance and nurtures talent. We welcome applications from talented individuals who share our values and are passionate about delivering exceptional results.