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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
What you will do:
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.
- 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
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
What you will do:
The Systems Manager is responsible for supporting client systems including project support, quality control, training and configuration.
- 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
What you will do:
The TMF Manager is responsible for conducting activities associated with maintaining the overall health and completeness of the TMF. They act as TMF subject matter experts in managing the quality, completeness, TMF structure, TMF plans, inspection readiness, and compliance for TMF documentation. They provide training and support to staff, develop training materials for client projects, and lead remediation efforts. They provide expertise for the oversight and delivery activities associated with TMF health.
- Communicates regular updates to JiT staff on all aspects of the projects assigned
- Provides guidance, clarification, and strategy for regulatory requirements and compliance associated with TMF documentation
- Provides expertise to teams in the filing of TMF documents as per the specific agreed upon study index based on the TMF reference model
- Conducts reviews at Trial, Country, and Site level
- Conducts full reviews, completeness checks, or risk-based reviews of documents with compliance to customer TMF plan, business rules and SOPs
- Provides direction for TMF Management for assigned and ensures reviews are conducted in accordance with JiT quality standards
- Initiates start-up activities that support TMF management for all assigned studies
- Uses JiT templates to develop business documents that support TMF management activities
- Attends study team meetings ensuring that TMF gaps or quality issued are appropriately escalated within the team
- Maintains the overall health and completeness of the TMF for assigned studies
- Manages the TMF Quality Completeness Review for assigned studies
- Manages end of study eTMF activities, liaising with CRO partners to ensure compliance with SOPs and project timelines
- Supports inspection activities based on the needs of the client
- May serve as a Lead for TMF activities in preparation for regulatory inspections and audit.
- Coordinates workload and assesses completed work of Staff assigned to the study
QUALIFICATIONS AND REQUIRED EXPERIENCE / EDUCATION
- Undergraduate degree and 5 years’ experience working with TMF
- Experience with full TMF lifecycle document management experience
- Experience with international regulatory record requirements and ethics requirements
- Strong proficiency in MS Office Suite
- Experience working with a variety of eClinical systems
CORE SKILLS AND KNOWLEDGE
- Ability to work in a fast-paced environment and meet deadlines
- Ability to drive collaboration and lead a team
- Strong teamwork and interpersonal skills
- Strong communication skills (written and verbal)
- Strong attention to detail
- Strong ability to apply business process rules to work activities and identify gaps in process impacting content review
- Strong organizational skills and ability to complete tasks to deadlines independently
- Good working knowledge of the TMF Reference Model Structure
- Understanding of the dynamics between Sponsor and CRO
- Ability to provide quality customer service through collaboration and critical thinking
- Understanding of Clinical Trial conduct, processes and functional groups involved in clinical trials
- Understanding of ICH/GCP and other application regulations pertaining to TMF management for clinical trials and regulatory submissions
- Strong organizational skills, problem-solving skills and critical thinking skills and ability to complete tasks to deadlines independently
What you will do:
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
What you will do:
The Project Manager is the key contact for a client to manage the activities associated with project deliverables. The Project Manager oversees, leads and manages internal project teams, providing guidance and ensuring alignment with the client and vendors.
- Serves as the primary point of contact between the client and Just in Time GCP – translates client needs into action plans with internal teams
- Organizes and leads the activities related to assigned projects
- Maintains and monitors the client SOW and contract agreement, ensuring quality and consistency in delivery of services
- Manages JiT project resources and budget in alignment with SOW
- Assigns project tasks to JiT project resources and ensures understanding of all aspects of the SOW
- Tracks timelines and deliverables and ensures that project remains on schedule and within scope and communicates potential issues
- Creates and maintains all project management deliverables as outlined in the project management methodology (i.e., project schedule, project workbook etc.)
- Leads internal and client facing meetings ensuring activities are aligned with the project scope and project plans
- Identifies changes in SOW and manages the Change Request processes and documentation as needed
- Engages with clients to establish a collaborative relationship that unifies team communications, decision making, risk mitigating and action taking
- Identifies continuous improvement opportunities to enhance operational efficiencies through reporting, process and metrics analysis
QUALIFICATIONS AND REQUIRED EXPERIENCE / EDUCATION
- Undergraduate degree and 5 years’ experience in project management
- Experience in providing consulting services
- Experience with international regulatory requirements and ethics requirements
- Experience with the drug development process
- Strong proficiency in MS Office Suite
- Experience working with a variety of eClinical systems (including TMF and CTMS)
- PMP Certification or equivalent preferred
CORE SKILLS AND KNOWLEDGE
- Ability to independently handle multiple tasks to meet deadlines in a fast-paced environment
- Ability to provide quality customer service through collaboration, leadership, critical thinking and innovation
- Ability to balance project needs with deliverables through problem-solving skills and creativity
- Ability to work effectively with roles/perspectives across all levels of organization
- Understanding of Clinical Trial conduct, processes and functional groups involved in clinical trials
- Strong critical thinking skills with excellent attention to detail
- Strong teamwork, organization, interpersonal and problem-solving skills
- Strong communication skills (written and verbal)
What you will do:
The Business Analyst supports consulting services for Just in Time GCP (JiT) clients, and within JiT process improvement projects. This includes developing process workflows, implementing eClinical strategies and project collaboration with clients and internal teams.
- Develops, applies, and aligns best practice standards for processes based on an understanding of Global Development regulations and guidance
- Develops and provides training to clients
- Performs process analysis to deliver process flows and RACI documentation
- Performs analysis to identify efficiency opportunities
- Develops and implements eClinical systems strategies to support the utilization of eClinical systems in the execution and oversight of clinical trials across a combination of system types
- Supports change management and communications activities
- Collaborates with JiT teams to ensure that project remains on schedule and within scope for their responsibilities
- Supports business development efforts and contributes to the generation of new business for Consulting, as applicable
QUALIFICATIONS AND REQUIRED EXPERIENCE / EDUCATION
- Undergraduate degree and 3 years of clinical operations and/or information management consulting experience
- Experience working with applications for projects and Clinical activities (e.g., Veeva, Documentum, SharePoint, IMPACT, Medidata, etc.)
- Certification on leading R&D technology platforms preferred
- Previous client interaction experience preferred
- Experience with the drug development process preferred
- Experience working with a variety of eClinical systems
- Strong proficiency in MS Office Suite
CORE SKILLS AND KNOWLEDGE
- Ability to independently handle multiple tasks to meet deadlines in a fast-paced environment
- Ability to balance project needs with deliverables through problem-solving skills
- Ability to provide quality customer service through collaboration, leadership, critical thinking, and innovation
- Knowledge of industry standards involved in clinical trials
- Strong ability to be detail oriented
- Strong communication skills (written and verbal)
- Strong organizational skills, problem-solving skills and critical thinking skills
