Senior Clinical Operations Process & Study Training Specialist

Summary

Join Apogee Therapeutics as a Sr. Clinical Operations Process & Study Training Specialist! You will be responsible for developing and implementing study-specific training across all programs using the Learning Management System (LMS). Maintain compliance with GCPs, SOPs, and regulatory guidelines. Collaborate with cross-functional teams, manage the LMS platform, and deliver training sessions. The ideal candidate possesses a bachelor's degree, 5+ years of clinical experience, and proficiency in LMS. Apogee offers a competitive compensation and benefits package, including flexible PTO, company-wide shutdowns, and professional development opportunities.

Requirements

• A bachelor's degree and relevant professional experience are required
• A minimum of 5 years of clinical related experience
• Proficiency in LMS with knowledge of utilization features is required
• Ability to develop engaging and effective study training materials, including e-learning modules and presentations
• Knowledge of the principles and practices of SOP management as applied to the pharmaceutical/biotech or contract research organization industry related to study training
• A solid understanding of clinical research with thorough understanding of clinical trial processes, regulatory requirements, and GCP guidelines pertaining to study training requirements
• Attention to detail and commitment to quality
• Excellent interpersonal and decision-making skills
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver department objectives
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with cross functional teams and within assigned timelines
• Experience working in a growing, fast paced organization
• Collaborative team-player
• Excellent written and verbal communication to deliver study training effectively and interact with diverse stakeholders
• Successfully exhibit Apogee’s C.O.R.E. values: C aring, O riginal, R esilient and E goless

Responsibilities

• Support and uploading course materials within the LMS platform, including e-learning modules, videos, quizzes, and assessments, tailored to specific clinical trial protocols and study procedures
• Assign and link study training documents through the LMS
• Administering the LMS, including user access control, assigning courses to appropriate staff, tracking course completion, and generate reports on training progress and compliance
• Support in the development and the maintenance of a cross functional role-based study training matrix
• Support the delivery of instructor-led training sessions, both in-person and virtually, for clinical study teams
• Support with ensuring all training materials and delivery methods adhere to relevant regulatory guidelines (e.g., GCP, ICH) and company standards
• Monitor learner performance through assessments and identifying areas for improvement, providing targeted training interventions (i.e. lessons learned, CAPAs, workshop and email blast) when necessary
• Provide support in SOP development and supporting documentation
• Work closely with clinical operations teams and/or cross functional teams to align training needs with study requirements
• Support in inspection readiness exercises with team related to study training and any reconciliation or gap processes
• Ensure effective preparations for regulatory inspections related to study training
• Support strategic initiatives in preparation for agency inspection readiness

Preferred Qualifications

Position requires up to 20% travel - including 2 All Hands Meetings plus functional meetings

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve