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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 Records Management Operations Lead is responsible for developing, and leading staff supervisors and team to align with company visions and values. With a focus on document processing, including uploads, classification and document quality checks, the Operations Lead provides SME knowledge to ensure 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, 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
The Systems Manager is responsible for supporting client systems including project support, quality control, training and configuration.
Responsibilities
- Supports system services activities for assigned clients including user access management, review of validation documentation, training verification and Systems User Acceptance Testing execution
- Performs quality check (QC) of configurations or other systems documents
- Provides support for projects to ensure that project remains on schedule and within scope
- Maintains Trackers
- Creates Audits and Correct Failed documents in Trial Interactive Audit Module
- Performs eTMF Room Build and Study Set Up Form Reviews
- Configures verification tasks
- Communicates with internal team regarding trends developing
Qualifications
- Undergraduate degree preferred and 3 years systems experience
- Systems certification preferred
- Strong proficiency in MS Office Suite
- Experience working with a variety of eClinical systems and ability to learn new technologies
- Ability to handle multiple tasks to meet deadlines in a fast-paced environment
- Basic critical thinking skills
- Acts as own career advocate
- Detail-oriented and ability to complete tasks independently
- Good teamwork, organizational, interpersonal and problem-solving skill
The Records Supervisor supervises the team ensuring quality standards are met and communicates trends to appropriate individual. The Records Supervisor also reviews client Trial Master File (TMF) records and performs TMF remediation activities to ensure that the records meet client quality standards.
Roles and Responsibilities
- Supervises a team of Records Associates and ensures quality standards of work product for team
- Participates in the hiring and selection process for staff through participation in the interviewing and onboarding processes
- Assigns workload for Records Associates
- Proactively identifies knowledge gaps and develops staff competencies to address these gaps
- Provides support and career development through positive environment to retain and grow members within organization
- Performs quality oversight reviews of Records Associates
- Onboards and trains new team members
- Participates in TMF Record Processing
- Performs record quality checks based on client business documents and records standards
- Performs review of record metadata to ensure it aligns with client business rules
- Performs secondary quality checks of records and applies self-evident corrections as per client business rules
- Ensure that documents have been categorized correctly and metadata has been assigned based on client processes and business rules
- Updates completeness tool with 1572/DOA information
- Uploads and classifies documents to the eTMF
- Performs record quality checks prior to document upload based on client business documents and records standards
- Assigns metadata based on client business standards
- Manages assignment of reconciliation and/or remediation work
Qualifications and Required Experience / Education
- Up to 3 years’ experience working within Trial Master File
- Previous management/supervisory experience preferred
- Strong proficiency in MS Office Suite
- Proficiency working with eClinical systems
The Systems Administrator is responsible for supporting client systems including project support, quality control, training and configuration
- Support managers and project teams in delivering eClinical systems services for clients:
- User Access Management
- Creating systems trainings for internal purposes and use with clients
- Systems User Acceptance Testing execution and client support
- Participate in eClinical systems implementations, including configuration and validation exercises
- Perform QC of configurations or other systems documents
- Provide support for projects to ensure that project remains on schedule and within scope
- Maintain trackers
Qualifications
Minimum of 1 year experience in computer systems management or college degree with focus in computer systems
Excellent attention to details
The SOP Writer must have a strong working knowledge of the clinical trial process.
- Act as Consultant in the development of procedures that support Clinical Operations and IT functions, such as Trial oversight, Trial Management, TMF Management and Systems Management.
- Support the project team in prioritizing, planning and documenting procedures based on client business processes
- Author policies, procedures, templates as required by scope of projects
- Review and gain feedback on deliverables with client stakeholders
- Support project team in process workshops
- Assist Project Managers in identifying project issues
- Coordinate procedure authoring across a team of writers, if applicable
- Remain current on Health Authority expectations related to clinical trial activities.
- Ensure all work activities are performed in compliance with GCP requirements.
Qualifications
- Minimum of 8 years’ experience in policy and procedures authoring or relevant technical writing.
- Experience with authoring Clinical procedures and policies
- Ability to align best practice with customer needs
- Knowledge of drug development process
- Critical thinking skills with strong problem-solving skills.
- Excellent written and verbal communication skills
