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General Description:

The Associate Director (AD), GCOE Learning and Development will be responsible for creation, implementation, and maintenance of Global Clinical Operations (GCO) department and role based training programs. Close collaboration with functional area representatives and subject matter experts is required to ensure that training needs are addressed. This individual will support a team of regional managers to ensure process and training is standardized globally, while allowing for necessary regional specifications. The AD is expected to plan, evaluate, and recommend on learning strategy for the department. Additionally, they will engage with process improvement, compliance, and quality functional teams to assist in driving change management and process compliance through training methods. This individual will also present compliance and performance based learning metrics to GCO stakeholders and the leadership team. The AD will provide line management, people development, and performance management as well as support/lead development and implementation of department process and policies.

Essential Functions of the job:

Global Clinical Operations Training:

+ Oversee and support learning business partners in the creation and maintenance of global and regional departmental and/or role based training programs.

+ Collaborate with cross-functional teams within Clinical Operations to identify training needs and priorities.

+ Design training materials, presentations, e-learning modules, and other educational resources tailored to different roles and levels within clinical operations.

+ Reviews SOPs and training documentation resulting from new processes or process improvements and rolls out GCO training and/or lessons learned, as appropriate.

+ Lead the delivery of training programs through various modalities such as instructor-led workshops, webinars, virtual classrooms, and self-paced online modules.

Maintain Learning and Development Metrics and Evaluate Effectiveness of Programs:

+ Evaluate the effectiveness of training programs through participant feedback, performance metrics, and assessments.

+ Identify opportunities for content enhancement based on industry trends, process changes, and inspection results.

+ Engage closely with functional business partners to respond to process metrics and trending data to identify gaps.

+ Present role based proficiency metrics to GCO stakeholders and leadership team.

+ Monitor and present training compliance metrics globally.

Process Improvement:

+ Collaborate with process improvement, compliance, and quality teams to lead in change management efforts.

+ Implement change using innovative training/learning techniques to ensure standardization of processes globally.

+ Serve as subject matter expert on strategic initiatives.

+ Support in development and/or maintenance of global forms, templates, guidance documents, and or reference tools.

+ Facilitate and/or lead change management activities.

+ Support in vendor selection for process improvement initiatives.

Supervisory Responsibilities:

+ Manage team in accordance with organization’s policies and applicable regulations

+ Direct internal staffing and performance management including hiring, training, coaching, and performance reviews

+ Drive team members to improve their efficiency and effectiveness at prioritizing work and improving performance.

+ Ensure prioritization of activities and resourcing is in line with clinical development programs.

+ Drives for operational excellence

+ Foster a collaborative highly integrated culture

+ Maintain a positive, results orientated, collaborative highly integrated culture

Computer Skills:

+ Efficient in Microsoft Word, Excel, Project, PowerPoint, and Outlook.

+ Experience with learning management systems (LMS) and e-learning authoring tools.

Qualifications:

+ Bachelor's degree in life sciences, healthcare, education, or related field

+ Minimum 8 years of experience in clinical operations within the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Experience in training, process improvement, and/or project management required.

+ Experience in end-to-end clinical trial processes including experience in one or more key functions (e.g., Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance.).

+ Thorough understanding of ICH-GCP regulations.

+ Strong communication and presentation skills, with the ability to effectively convey complex information to diverse audiences.

+ Proven ability to collaborate cross-functionally and influence stakeholders at various levels of the organization.

+ Demonstrated expertise in instructional design, adult learning principles, and training program development.

+ Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements.

Travel:

+ Travel required for business purposes

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.