Clinical Operations Process & Study Training Manager

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.  This role requires ensuring adherence to GCPs, SOPs, and regulatory agency guidelines, while maintaining knowledge of study operational processes to guarantee study training compliance across functions. The Process & Study Training Manager will support implementation of best practices and processes in support operational excellence and inspection readiness for cross-functional teams.  This role will also engage in regular communication with internal study team members to provide study training updates, manage study training effectiveness, address potential study training challenges across therapeutics area, and troubleshoot routine inquiries in real-time.

Key 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.

Ideal Candidate

• 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: Caring, Original, Resilient and Egoless
• Position requires up to 20% travel - including 2 All Hands Meetings plus functional meetings