Job Description

Summarized Purpose

Oversees and coordinates training and/or quality programs and activities. Schedules training for new employees, identifies training gaps and develops and delivers training programs and curriculums to promote continuous improvement.

A day in a life

Leads or performs quality reviews of MIA and MIS staff customer interactions and associated documentation and coordinates and assists with corrective action plans if needed.Ensures program compliance with corporate, departmental and client policies and procedures including SOPs and applicable health authority regulations (e.g. FDA, EMEA), as well as standard inquiry management and documentation practices.May serve as a liaison with the clients for training or quality topics.Schedules, develops and delivers training courses and content for all staff members. Conducts product or disease state training for staff members as required.Monitors effectiveness of training and observes training sessions, trends and assesses changes in employee performance. Modifies training to increase beneficial outcomes.Integrates training with the client while negotiating organizational differences in culture, management structure and staffing. Liaises with the client, department management and staff for all training related topics. Maintains program training documentation in audit-ready status.Conducts call and documentation review of staff members' work and monitors accuracy and completeness of information provided, including clinical content. Ensures program consistency relative to compliance with the organization and client policies/procedures. Evaluates quality trends across the program and provides feedback to the management team. Tracks and documents Quality Events. Develops continuous improvement initiatives based on gaps and trends identified.Provides support for program-related audits.May assist with department projects

Education and Experience: 

Bachelor's degree in nursing or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years). In most cases a license will be requiredIn some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: 

Strong understanding of applicable health authority (e.g. FDA, EMA) or local regulationsStrong clinical trial knowledge, preferredAbility to work US daytime business hoursGood knowledge of drugs and drug informationAbility to perform call/document review, including complex clinical discussions and provide clear and concise feedbackFirm organizational and time management skillsStrong attention to detail and ability to multi-taskStrong verbal and written communication skillsSolid problem-solving skillsStrong computer skills including Microsoft OfficeAbility to train and mentor othersExcellent language skills (comprehension, speaking, reading and writing) must be demonstrated if the position requires languages other than EnglishAbility to work in a team environment and/or independently as needed