Head of AI Transformation & Enablement leading AI initiatives at Novartis' Global Clinical Operations to drive AI adoption and operational excellence.
EG
Onsite Phase 1 Clinical Research Director – Manager of Clinical Operations
Posted last week
About the role
- Manager/Director of Clinical Operations overseeing clinical trials at ERG in Miami, FL. Responsible for protocol adherence and operational management of studies.
Responsibilities
- Lead and mentor the clinical operations team to promote a collaborative and efficient environment.
- Ensure protocol compliance and maintain high-quality standards across studies.
- Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies.
- Oversee human resources functions, including staff evaluations, recruitment, and training.
- Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies.
- Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators.
- Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation.
- Conduct study closeout procedures.
- Perform additional duties as needed to adapt to the evolving needs of CPMI.
- Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP
Requirements
- Bachelor's degree in a scientific or healthcare-related field
- 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role.
- Strong understanding of FDA, ICH, and GCP regulations and guidelines
- Strong communication, organizational, and leadership skills.
- Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software.
- In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out
- Experience managing and mentoring a team of clinical operations professionals
Benefits
- Health insurance
- Dental & Vision Insurance
- Matching 401k Retirement Plan
- Paid Time Off (PTO)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Associate Director at Verastem Oncology overseeing phase 3 global clinical trial. Leading operational execution and compliance with regulatory guidelines for oncology - focused studies.
Clinical Project Manager II managing biomarker studies for clinical trials at Syneos Health. Overseeing operations, ensuring project success, and providing leadership to cross - functional teams in a fully remote role.
SSO Study Start - Up Manager guiding study planning and activation deliverables across various regions. Ensures compliance with regulatory requirements and collaboration with global study teams.
Head of AI Transformation & Enablement for Global Clinical Operations defining AI strategy and leading AI transformation initiatives in Switzerland's healthcare sector.
Immunology Therapeutic Area Lead driving early development strategies for immunology therapeutics with cross - functional teams. Leading strategic planning and operational oversight for clinical programs.
Lead clinical execution of trials for a global healthcare company. Oversee study protocol adherence and collaborate with cross - functional teams in clinical research initiatives.
Senior Study Manager leading operational planning and execution of clinical trials for pharmaceutical company. Collaborating across global, cross - functional teams in ophthalmology trials.
Study Manager contributing to operational planning and execution of clinical trials in ophthalmology. Collaborating with cross - functional teams to develop skills in a global environment.
Scientist contributing to the scientific planning and execution of clinical trials within the ophthalmology field. Developing leadership, technical skills, and scientific acumen in a global team context.