(Sr*) Manager / Associate Director, Global Clinical Development Operations Training Management

Open for hire at one of the following locations –  Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 6231 

 

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(Sr*) Manager / Associate Director, Global Clinical Development Operations Training Management 

 

Job Summary: We are seeking an experienced and team-oriented (Sr*) Training Manager or Associate Director to support the development and implementation of training solutions for our Global Clinical Development Operations (GCDO) team. The successful candidate will work closely with the Director, GCDO Training Management (and other cross-functional stakeholders) to ensure that training processes and curricula are aligned with internal SOPs and systems, regulatory standards, and industry best practices. The successful candidate will have experience in designing, developing, and implementing effective and engaging training solutions that incorporate adult learning principles and instructional design methodologies. The candidate will be responsible for ensuring that all training processes and documentation are GCP-compliant and support a flexible and agile working environment that promotes a culture of learning, continuous improvement, and quality.

 

Key Responsibilities:

• Support the development and execution of a comprehensive training strategy for the GCDO team, with a focus on Clinical Operations.

• Develop effective and engaging training processes/materials/sessions and support knowledge management.

• Monitor training efficiency and effectiveness, identify training gaps, and partner with key stakeholders to ensure alignment with departmental/organizational priorities.

• Develop and execute training strategies for new, improved processes (including GCP-compliant training and documentation) that support an agile working model.

• Support the development and maintenance of GCDO training programs, ensuring all training reflects current industry best practices and regulatory standards in line with associated internal processes and systems.

• Manage training of GCDO personnel and ensure high training quality standards and compliance.

• Collaborate with cross-functional training colleagues to ensure harmonization of processes across training programs.

• Support training development and delivery for new hires and existing staff, including internal best practices, industry regulations, and processes/systems.

• Collect and consolidate relevant feedback from new and current employees, including the review and analysis of learning evaluation data.

• Support change management for new training initiatives and curricula.

• Serve as a departmental Training Admin for Veeva Quality, responsible for managing and maintaining GCDO training content in the Training Management module.

 

Required Qualifications:

 

Education:

•Bachelor's degree in a business, science, or healthcare related field or equivalent. Master's degree preferred.

 

Work Experience:

• Minimum four (4) years (Manager) / eight (8) years (Associate Director) working within Clinical Operations, Clinical Trial Management, Clinical Trial Monitoring, or a related function within pharmaceutical/biotech/CRO or related fields.

• Broad experience in the pharmaceutical industry with a strong understanding of clinical development.

• Expert knowledge of ICH/GCP, FDA/MHRA/EMA regulations, EU Clinical Trial Directive, and other applicable industry regulations, processes, and practices.

 

Learning & Development:

• Extensive experience in training development and curriculum design, preferably in a pharmaceutical (GxP-regulated) environment.

• Ability to deliver training on critical aspects of Clinical Trial Management such as ICH/GCP, Sponsor Oversight, Risk-Based Quality Management, Inspection Readiness, etc.

• Strong working knowledge of adult learning principles, instructional design methodologies (including ADDIE and/or SAM model), and e-learning and blended learning approaches.

• Experience with learning assessment/e