Avanir Pharmaceuticals

Manager, Clinical Training

Location
Aliso Viejo, CA, United States
Posted
Oct 08, 2020
Ref
R2534
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Clinical Training Manager will direct and oversee the delivery of clinical training to the organization by guiding the development of a high-quality curriculum in partnership with applicable stakeholders and subject matter experts. This individual will work closely with clinical operations management to monitor effectiveness of training, identify areas of potential quality and compliance risk and create and implement strategies for improvement.

Essential Job Functions:
  • Develop a training roadmap for the clinical organization that meets business and regulatory requirements for both in-house and field-based teams
  • Collaborate with the Head of Clinical Operations and R&D Management to ensure successful training for new and updated clinical policies and procedures
  • Oversee the development and delivery of the clinical training program to include organizational role-based onboarding, skills refreshers, new releases and ongoing process trainings using multiple modalities where necessary
  • Reevaluate training on a regular basis to ensure materials are consistent with current operational processes
  • Determine training needs by analyzing issues that impact quality and create a plan of action to drive improvement
  • Promote the use of eLearning and select and build training modalities to meet individual-use in support of role and study specific needs
  • Manage training and track compliance within the Learning Management System in collaboration with R&D Operations Management
  • Support development of clinical systems training to align with role-based systems use in collaboration with Clinical Information Systems Administrator and Clinical Operations Management
  • Lead the development of role and activity-based RACI Matrices for the clinical organization
  • Own the reporting and communication of training performance metrics to all the relevant stakeholders
  • Provide oversight of training vendors to ensure alignment with organizational requirements and appropriateness of content
  • Assess training gaps and design applicable trainings as appropriate
  • Support audit/inspection and CAPA activities as assigned
  • Support process development and improvement activities as assigned
  • Support Investigator Meeting and other meeting content development as assigned


This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Educations/ Qualifications:
  • 8+ years of experience in clinical training management preferred
  • BA/BS degree or equivalent experience
  • Proven knowledge of clinical trials and expertise in training clinical teams
  • Experience conducting a training needs analysis with implementation of the full Training Cycle: Identify, Design, Delivery, Evaluation
  • Excellent verbal, written and presentation skills
  • Experience implementing a wide range of change management and process improvement activities
  • Ability to develop and implement team goals and strategies based on broader organizational goals
  • Ability to analyze large volume of data points, identify issues and recommend solutions
  • Ability to travel as required to carry out responsibilities.
  • Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, Visio, etc.).


Physical Requirements:

This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.

Work Environment:

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.

EEO Statement:

As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.

Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.