Clinical Research Training Manager

How You'll Make an Impact:

Responsible for managing, organizing, and delivering Clinical Research training. Assists with onboarding of new Study Management staff. The Clinical Research Training Manager may be assigned Clinical Study Management activities approximately 15-20% of the time.

What You'll Do:

• Primary creator and driver of Study Management Training. Under the direction of Sr. Manager, Clinical Research Training, manages, organizes, and delivers Study Management training which includes but is not limited to:
• Study Management (i.e., Study Manager, Clinical Trial Associate, etc.) Training
• Developing Study Management new-hire training guidelines and presentations
• Preparing Study Management new-hire training materials
• Scheduling and delivery of Study Management new-hire training
• Filing and tracking Study Management new-hire training documentation
• Coordinating and/or delivering Clinical Systems training (i.e., CTMS and eTMF) for Study Management staff
• Performs routine gap assessment to determine ongoing training gaps and / or training needs

Study Management Onboarding:

• Partners with hiring manager to initiate Study Management New Hire Onboarding checklist

Ongoing Clinical Research Staff Training:

Assists with development and delivery, in partnership with the Sr. Manager, Clinical Research Training, for the Clinical Research Department for various learning topics that include, but not limited to:

• Procedures
• Forms and Templates
• Process Changes
• Guidance and Regulation Changes
• Identified Training Gaps of all Clinical Research Staff, when partnered with their Managing Team

Responsible for maintaining and tracking non-study specific training records (i.e., department training, GCP training, etc.) for the Clinical Research Department (i.e., Study Management, Monitoring, Clinical Relations, Surgical Specialist, etc.)

Performs additional tasks to support the Clinical Research Training Function which include, but are not limited to:

• Collection of new hire documents (e.g., CVs, certifications, prior GCP training, etc.
• Building and distribution/shipping of new hire training materials (e.g., CRA Leaning Lab Training Materials, New Hire Orientation, etc.)

Collaborate with Clinical Research Operations and Clinical Compliance to align training with audit and compliance priorities

Assists with creation and/or review of clinical forms, tools and templates

Conduct Clinical Study Management Activities (Approximately 15-20%):

• Assist with study start-up activities as needed
• Provide study management support in preparation of audits
• Assist with Clinical Department administrative tasks as needed
• May be assigned to special projects and initiatives as needed

How You'll Get There:

• Proven ability to teach complex subject matter to individuals with vast degree of variance in experience
• Proven expertise in large group facilitation, adult learning methodologies and presentation skills
• Demonstrated ability to understand and embrace new technologies
• Demonstrated skill in written and verbal communication
• Demonstrated critical thinking and problem-solving skills
• Strong public speaking / presentation skills and the ability to train others
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments
• Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred
• Knowledge and understanding of Good Clinical Practices (ICH E6 R3)
• Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies
• Must have proficient computer skills and experience with Microsoft Office
• Ability to demonstrate and foster teamwork within the group.
• 8+ years of Clinical Research experience with at least 4 years work experience as a Clinical Trial Associate and / or Study Manager
• Bachelor's Degree, strong Clinical Research experience and ophthalmology experience

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