Quality Contract R&D Training Manager - Columbus, OH Columbus, OH

Job Title: Contract R&D Training Manager

Location: Columbus, OH

Contract: 12 months

The Importance of the Role 

This individual will be a member of the QA Compliance team supporting research & development training needs, primarily focused on preclinical and clinical genetic therapies research functions. This individual will be responsible for adhering to company’s corporate GxP Training Policy and procedures and will perform various training responsibilities to ensure ongoing compliance. This position will reside on-site in Columbus, OH and will perform corporate training tasks work closely with Testing Facility Management (TFM) and site management at Company Genetic Therapy Center of Excellence (GTCOE) to ensure sustained compliance. This position involves a variety of training management responsibilities, including the oversight and support of improvement initiatives, which includes revamping R&D training roles and curricula; administration of the training management system and process improvements; and ensuring training completion is performed on-time documented, completed, and archived in a compliant manner. 

The Opportunity to Make a Difference

• Ensure compliance with corporate policies and procedures.
• Support onboarding and offboarding of personnel, including establishing training requisites with hiring manager. 
• Assess training needs across R&D functional areas, working in collaboration with QA Compliance, Testing Facility Management (TFM), and site leadership to ensure training is fit for purpose in accordance with each learner’s job description and scope of responsibility. 
• Maintain Company’s GxP Training Learning Management System (LMS) (Veeva Training Vault & Learn GxP content) for continued compliance, which includes maintaining learner roles, curricula, training requirements and training assignments.
• Partner with training management to revamp training roles and curricula based on QA Corporate and local R&D business needs, ensuring processes & naming conventions are scalable and sustainable for future growth.
• Provide daily support to personnel to meet business goals and priorities, including the review of all new/revised documentation being processed that impact GTCOE operations. 
• Design and control custom training materials (eLearning SCORM courses & microlearning videos), as assigned. Work with functional SMEs to ensure content is complete, accurate, and designed properly to ensure effective adult learning.
• Conduct annual curricula reviews with GTCOE functional management and ensure employee/contractor job descriptions & CV documentation is up to date and inspection ready.
• Drive on-time training completion across GTCOE functional teams to meet KPI targets.
• Update / maintain training procedures, templates, forms, and records, as assigned.
• Provide training support during audits/regulatory inspections, as assigned.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $54.83 – $65.51 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.

We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.