Sr. Clinical Operations Process & Study Training Specialist

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking   an experienced Sr. Clinical Operations Process & Study Training Specialist to support the development and implementation of study-specific training across all programs via the Learning Management System (LMS), ensuring that cross-functional study teams receive comprehensive training on study protocol and procedures. The ideal candidate will support adherence to GCPs, SOPs, and regulatory agency guidelines while maintaining knowledge of study operational processes to ensure study training compliance. This role may also be involved in supporting the implementation of best practices and processes in support of operational excellence and inspection readiness. Additionally, you will engage in regular communication with internal study team members to provide study training updates, support the management of study training effectiveness, address potential study training challenges across therapeutic areas, process all training assignments/requests and troubleshoot routine inquiries in real-time.

Key Responsibilities

• Support and Maintaining Training Content:
  • 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.

• Managing LMS Platform:
  • 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.

• Facilitating Training Delivery:
  • Support the delivery of instructor-led training sessions, both in-person and virtually, for clinical study teams.

• Compliance Oversight:
  • Support with 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:
  • 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.

• Support in SOP Development
  • Provide support in SOP development and supporting documentation.

• Collaboration with Clinical Operations Leadership and key Stakeholders:
  • Work 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.
  • Ensure effective preparations for regulatory inspections related to study training.
  • Support strategic initiatives in preparation for agency inspection readiness.

Ideal Candidate

• 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