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At Just in Time GCP, we welcome the industry’s best and brightest to join our growing team. We keep a high-energy, productive environment and we work together to deliver excellence. However, we live by the work hard, play hard philosophy and we truly value the concept of “Family First.” If this sounds like a place you would like to work, please see our available positions. You can apply by sending an email to info@justintimegcp.com with your resume and the position you are interested in.
Check back frequently as we are continually adding new opportunities as we expand. All positions are remote based.
Careers
Available Career Opportunities
The Training Manager leads and manages the development and execution of training initiatives and solutions for the team to ensure alignment with GCP regulatory compliance and client standards.
Responsibilities
- Leads the development and execution of training initiatives and solutions for training that support desired business and performance outcomes.
- Identifies and addresses training needs, maintaining a consistent culture regarding training, and overseeing the effectiveness of training programs, outcomes, and resources
- Manages and maintains the Learning Management System (LMS) to ensure compliance with applicable regulations, GCP standards and leadership’s quality management strategy
- Designs, develops, and delivers internal JiT training and/or leverages existing solutions to ensure the quality of Services deliverables
- Monitors, evaluates, and ensures internal training programs meet department standards for instructional design and development standards as well as business partners’ expectations
- Provides engaging communication about training programs to encourage employee participation and emphasize the benefits and value of training and education
- Manages and participates in department projects including the planning, design, development, testing, and implementation phases
- Collaborates with department leadership and contributes to strategic planning, innovation, and continuous improvement efforts
- Ensures training follows GCP regulations and industry best practice
Qualifications
- Undergraduate degree and 5 years’ experience in in the Life Sciences space supporting training; clinical trial management experience a plus
- Experience with key training principles including conducting needs analysis, scoping, designing, developing, and evaluating training modules
- Experience providing and executing presentations and conducting team building
- Experience applying proactive approaches to support GCP compliance
- Experience with drug development process
- Experience working with a variety of eClinical systems and ability to learn new technologies
- Strong proficiency in MS Office Suite
The Operations Lead (OL) is the key contact for a client to manage the support activities associated with TMF study management and client deliverables. The OL provides crucial TMF quality oversight and support to the internal teams and with the client and their vendors (CROs). This role leads and manages a team of Services staff, providing direction and guidance and developmental opportunities as a line management function.
This position is remote based and requires up to 20% travel.
Responsibilities
- Partners with clients to derive optimal value from our services, ensuring a seamless flow of client requirements through the delivery services process
- Serves as project leader between the client and Just in Time GCP – translates client needs into action plans with the internal team (i.e. determines responsibilities and timeframes and negotiates resources with internal departments as required)
- Leads and manages assigned team of staff in accordance with organization’s policies
- Supports business development efforts and contributes to the generation of new business for TMF Services Operations, as applicable
- Escalates trends in issues to leadership
- Actively identifies continuous improvement opportunities to enhance operational efficiencies through reporting, process and metrics analysis
Qualifications and Education Requirements
- Undergraduate degree and 5 years’ experience in working in the pharmaceutical industry, clinical research organization and/or related role
- Previous line management or project leadership experience
- Experience with international regulatory record requirements and ethics requirements
- Experience with TMF and records management and oversight
- Experience of drug development process
- Experience with international regulatory record requirements and ethics requirements
- Experience with regulatory agency inspection(s)
- Experience with client management/account management and basic project management methodologies is a plus
- Experience working with a variety of eClinical systems and ability to learn new technologies
- Strong proficiency in MS Office Suite
ROLE AND RESPONSIBILITIES
- Participates in TMF Record Processing
- Uploads and classifies documents to the eTMF – Performs record quality checks prior to document upload based on client business documents and records standards and assigns metadata based on client business standards
- Communicates trends and issues to the Supervisor
- Participates in reconciliation and/or remediation work
- Ensures all work activities are performed in compliance with requirements of Good Clinical Practice
- Performs other activities as assigned
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Minimum of 2 years’ experience processing documents into aTrial Master File
- Knowledge of clinical study records
- Strong proficiency in MS Office Suite
- Experience working with eClinical systems
- Understanding of the TMF Reference Model structure
