Clinical Research Training Manager

Glaukos•San Clemente, CA

About The Position

The Clinical Research Training Manager is responsible for managing, organizing, and delivering Clinical Research training. This role also assists with the onboarding of new Study Management staff. The Clinical Research Training Manager may be assigned Clinical Study Management activities approximately 15-20% of the time.

Requirements

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.
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.
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.

Nice To Haves

Experience in the medical device and pharmaceutical industry is preferred.
Ophthalmology experience is strongly preferred.

Responsibilities

Primary creator and driver of Study Management Training.
Manages, organizes, and delivers Study Management training.
Develops Study Management new-hire training guidelines and presentations.
Prepares Study Management new-hire training materials.
Schedules and delivers Study Management new-hire training.
Files and tracks Study Management new-hire training documentation.
Coordinates and/or delivers 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.
Partners with hiring manager to initiate Study Management New Hire Onboarding checklist.
Assists with development and delivery of training for the Clinical Research Department for various learning topics.
Maintains and tracks non-study specific training records for the Clinical Research Department.
Collects new hire documents (e.g., CVs, certifications, prior GCP training, etc.).
Builds and distributes/ships new hire training materials.
Collaborates 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.
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.