Clinical Operations Process & Study Training Manager - Remote

Overview

We are seeking an experienced Clinical Operations Process & Study Training Manager to oversee the development and implementation of study specific training across all programs via the Learning Management System (LMS). The ideal candidate will ensure that cross-functional study teams receive comprehensive training on study protocol and procedures within the clinical study team.

In Short

• Oversee development and implementation of study-specific training.
• Ensure adherence to GCPs, SOPs, and regulatory guidelines.
• Manage the Learning Management System (LMS).
• Facilitate instructor-led training sessions.
• Identify training gaps and provide targeted interventions.
• Support SOP development and management.
• Collaborate with clinical operations teams.
• Ensure inspection readiness related to study training.
• Monitor learner performance and compliance.
• Contribute to continuous improvement initiatives.

Requirements

• Bachelor's degree and relevant professional experience required.
• Minimum of 6 years clinical experience, including project management.
• LMS proficiency and instructional design skills.
• Knowledge of SOP management in the pharmaceutical/biotech industry.
• Solid understanding of clinical research and regulatory requirements.
• Excellent interpersonal and decision-making skills.
• Experience in a fast-paced organization.
• Collaborative team-player with strong communication skills.
• Experience in mock and regulatory inspection activities.
• Willingness to travel up to 20%.

Benefits

• Great culture based on C.O.R.E. values.
• Opportunity to work in a dynamic environment.
• Market competitive compensation and benefits package.
• Flexible PTO.
• Company-wide shutdowns each year.
• Commitment to professional growth and development.
• Regular in-person team meetings.