Clinical Operations Process And Study Training Manager

Summary

Join Apogee Therapeutics as a Clinical Operations Process & Study Training Manager! You will be responsible for developing and implementing study-specific training across all programs using the Learning Management System (LMS). This role requires ensuring compliance with GCPs, SOPs, and regulatory guidelines. You will create training materials, manage the LMS platform, facilitate training delivery, and identify training gaps. Collaboration with clinical operations teams and stakeholders is crucial. The ideal candidate possesses a Bachelor's degree, 6+ years of clinical experience, including 2+ years of project management, and LMS proficiency. Apogee offers a competitive compensation and benefits package, including flexible PTO, company-wide shutdowns, and professional development opportunities.

Requirements

• Bachelor's degree and relevant professional experience required
• Minimum of 6 years clinical related experience including 2 years of project management related skills with the ability to plan, organize, and execute study training initiatives on time and within budget
• LMS proficiency with expertise in managing and utilizing features of an LMS
• Instructional design skills with the 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 knowledge 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
• Possesses excellent planning, time management & coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with cross functional teams and within timeline
• 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
• Experience in mock and regulatory inspection activities
• Successfully exhibit Apogee’s C.O.R.E. values: C aring, O riginal, R esilient and E goless

Responsibilities

• Developing and maintaining training content: Creating and updating course materials within the LMS platform, including e-learning modules, videos, quizzes, and assessments, tailored to specific clinical trial protocols and study procedures
• Link final TMF documents as LMS training documents to assign study specific training to study team through the LMS
• Managing LMS platform: Administering the LMS, including user access control, assigning courses to appropriate staff, tracking course completion, and generating reports on training progress and compliance
• Develop and maintain a cross functional role-based study training matrix
• Facilitating training delivery: Support in the conduct of instructor-led training sessions, both in-person and virtually, for clinical study teams
• Compliance oversight: Ensuring all training materials and delivery methods adhere to relevant regulatory guidelines (e.g., GCP, ICH) and company standards
• Identifying training gaps and addressing issues: Monitoring learner performance through assessments and identifying areas for improvement, providing targeted training interventions (i.e. lessons learned, workshop and email blast) when necessary
• Support in SOP Development and Management May write and support in SOP development and supporting documentation
• May also contribute to the development/management of cross-functional processes and participate in implementation of initiatives
• Collaboration with Process Excellence Head and stakeholders: Working closely with clinical operations teams and/or cross functional teams to align training needs with study requirements
• Inspection Readiness Support in inspection readiness exercises with team related to study training and any reconciliation or gap processes
• May support in the management of CAPAs for the Clinical Operations team related to study training
• Ensure effective preparations for regulatory inspections related to study training
• Work with the clinical trial teams to identify operational issues/processes and opportunities for improvement to ensure study training compliance
• Co-lead strategic initiatives, either autonomously or collaboratively, which target continuous improvement and achievement of operational excellence to support 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