Training and Education Specialist - Clinical Operations - FSP (Remote)

Job Summary:

Support Training and Education areas to facilitate implementation of scientific, technical and compliance education programs and associated materials for those areas in scope e.g., clinical, medical, safety, regulatory and related quality management systems. This position enables education, learning, curriculum development and the sharing of best practices.

Support and collaborate with functional lines developing educational programs that ensure that colleagues meet or exceed the expectations of their roles as technical contributors and project team members.

Support the development/implementation of a variety of technical education materials and programs such as symposia, short web-based “adverts”; case studies, journal clubs; simulations, games, newsletters and other modes of education and communication to meet business needs.

Support the implementation of curricula within supported functional lines.

Support the integration of e-enabled educational programs, materials and blended learning solutions so that they can be launched and tracked in appropriate learning management system(s).

Support Training Education Lead to develop training implementation strategies for business process improvements(BPIs) to ensure the relevance to the roles supported.

Support Training Education Lead to manage external vendors(as required) for the design, development and implementation of education programs.

Support Training Education Lead to establish processes and maintain currency and accuracy of educational programs.

Job Responsibilities:

Needs Analysis & Planning:

• Engages with functional SMEs, to build robust content to respond to educational and compliance needs and requirements to meet scientific/technical and regulatory objectives.
• Develops and maintains a thorough understanding of business drivers, strategic pressures and educational needs from a variety of perspectives; colleague, manager, regulatory etc. and utilizes this knowledge to develop and implement educational plans
• Conducts needs analysis to determine best training intervention and approach

Program Development, Prioritization & Implementation:

• Identifies the key learning objectives, selects an optimum methodology, and makes recommendations whether to use internal services or outsource the work. Effectively utilizes and manages a network of subject matter experts to support the development of instructional materials. Manages associated project plans and budget
• Ensures implementation of appropriate educational programming to support management's business education priorities.
• Interfaces within departments to coordinate and utilize existing educational resources, programs and infrastructure to meet requirements
• Ensures regulatory training and education requirements are met and that program and implementation design maximizes training effectiveness
• Ensures consistent implementation of best practices, standards, and training across like roles
• Works with customer(s) to plan and execute forums and conferences to further the identification and transfer and of best practices
• Evaluates and collects metrics to determine if educational program met identified needs as well as continuous improvement opportunities
• Consistently applies project management principles to training and educational projects

Technical and Scientific Expertise:

• Develops instructor led and e-enabled learning and educational programs using a variety of tools such as Microsoft Office, Lectora, Articulate, Captivate, Camtasia and Breeze
• Utilizes sound project management principles in order to meet timelines, manage resources (people and budget) and delivers against agreed upon project deliverables
• Develops technical and scientific expertise necessary to effectively support and develop educational materials for assigned customers
• Manages training logistics and delivers training as needed
• Expertly manages all aspects of the learning management system to enable effective documentation practices, inspection readiness, metrics and compliance reporting
• Responds quickly and professionally to all customer queries regarding training materials, learning management system, reporting and compliance to maintain high customer satisfaction levels

Skills / Requirements:

• BA/BS degree in life science or relevant technical field is required.
• Fluent English oral and writing skills are required.
• Pharmaceutical training and education experience
• Knowledge of clinical research & drug development in a pharmaceutical environment.
• Demonstrated training design and development as well as project management expertise.
• Demonstrated experience in using information management tools and techniques
• Proven consultation and customer service skills
• Demonstrated experience in selecting and working with external training vendors
• Clinical & Regulatory Processes, Project and Process Management Organizational Development Training
• Presentation/Influencing Skills
• Systems Technologies
• Demonstrated knowledge of clinical research processes, drug development process and regulatory requirements
• Knowledge of client context, culture and RD business
• Ability to manage complex projects and cross- functional processes required Knowledge of organizational development principles and demonstrated success in implementing organizational development strategies
• Knowledge and demonstrated success in training and curriculum development and methods including implementation
• Demonstrated success/results in prior scientific/administrative education roles Demonstrated platform skills; experience presenting to large scientific/clinical populations
• Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption

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