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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 Systems Manager role includes analyzing, implementing, managing, networking and collaboration with internal and external clients to ensure quality deliverables throughout all phases a clinical trial. Systems Managers are responsible for overseeing and leading groups of people and projects to meet business and regulatory requirements.  Systems and computer skills along with strength in ability to problem-solve, be attentive to details and provide clear written and oral communication is critical to this roll.

Role and Responsibilities

  • Develop and implement eClinical systems strategies to support the utilization of eClinical systems in the execution and oversight of clinical trials across a combination of system types, including:
    • eTMF/eISF/CTMS
    • RIMS/RDMS
    • Direct Data Capture (DDC) and Electronic Data Capture (EDC)/eSource/eCOA/ePRO/eConsent
  • Oversee the strategy, management and integration of an eClinical systems, including vendors and technology.  This will involve hands-on participation in the configuration and maintenance of eClinical systems. 
  • Ensure change management is performed in alliance with the client’s CSV requirements and GXP standards Collaborate with clients and internal business process experts to establish and optimize operational workflows across one or more eClinical systems
  • Create and provide user training.
  • Partner with stakeholders throughout full lifecycle of eClinical systems integration, from defining business needs and eClinical systems selection through project planning, development, deployment, and end user adoption.
  • Provide ongoing management and functional oversight for all eClinical systems.
  • Provide business support and guidance to eClinical Systems Administrations on system/database administration
  • Serve as a Subject Matter Expert (SME) on optimization, implementation, and maintenance of eClinical systems.
  • Support systems services for clients, including study set-up, user access, and archive activities.
  • Collaborate with the Project Leads to ensure that project remains on schedule and within scope from a systems perspective.
  • Serve as a business administrator of the eTMF for JiT as well as for select clients, when required.
  • Contribute to the development of Just in Time GCP (JiT) best practices related to eClinical systems management.
  • Support the development of systems metrics reporting for both client and JiT management oversight.
  • Remain current on international Health Authority expectations related to eClinical systems
  • Work with Project Leads and Consultants to identify opportunities for client systems enhancement.
  • Participate in vendor relationship management activities to support Systems efforts and strategies.

Qualifications and Education Requirements

  • Minimum of 5 years’ experience in management of one or more eClinical systems
  • Working knowledge of GCP and systems ethics requirements, including HIPAA and/or GDPR
  • Working knowledge of international regulatory record requirements and ethics requirements a plus
  • Experience leading small teams
  • Bachelor’s Degree or other professional degree preferred
  • Veeva White Belt Certification highly desirable

Just in Time GCP is recruiting for an individual with experience in functional management who can effectively lead, inspire, and collaborate well with others. This position is responsible for planning, organizing, staffing, and supporting the growth and development of team members at Just in Time. Relationships built from knowledge, trust and collaboration are key to the success of a functional manager as they liaise with leadership and the JiT teams daily.

This position is remote based and requires less than 10% travel.

Role and responsibilities

  • Provide a positive working environment, with a focus on developing and retaining members in the TMF Services group
  • Support the alignment of activities and objectives of the TMF Services group with the organization’s core values, strategy, and vision
  • Support organizational growth through recruiting, hiring, and training of members to support business needs
  • Support the development and implementation of onboarding, training, and career development plans
  • Manage activities within functional area to align with specific client needs and JiT overall objectives
  • Serve as subject matter expert (SME) on the review of the Trial Master File to develop and mentor staff
  • Conduct review of work performed by direct reports to ensure quality deliverables including tasks related to performance evaluations, feedback, and development plans
  • Perform TMF project tasks as appropriate based on resourcing gaps, aggressive timelines, or training needs
  • Support business development by developing process improvements, optimizing staff performance and utilization, trending and providing ongoing feedback
  • Ensure all work activities are performed in compliance with requirements of Good Clinical Practice

Qualifications and Education Requirements

  • Minimum 5 years’ experience in TMF Management with knowledge of the drug development process
  • Minimum 1 year experience in Functional Management
  • Bachelor’s degree or other professional degree preferred
  • Working knowledge of international regulatory record requirements and ethics requirements
  • Strong verbal and written communication skills, combined with computer experience including Microsoft Suite
  • History of providing quality customer service through collaboration, leadership, critical thinking, and innovation
  • Just in Time GCP is recruiting for an individual with experience in leading projects and teams to help deliver quality services. This individual is responsible for leading client projects, business development, system support, KPIs, and the overall health of the Trial Master File (TMF) from start-up, health, and completeness reviews, to close-out activities. Relationships built from trust and collaboration are key to the success of a TMF Lead as they work directly with the client and internal team members daily.

This position is remote based and requires less than 10% travel.

Role and responsibilities

  • Act as Project Lead on assigned client projects and work with internal SME and clients to analyze, develop, and implement processes that support business use of electronic clinical systems.

    • Ensure the development and execution of the project plan that supports business process, system implementation and management, and validation activities
    • Work with Director of TMF Services to ensure project remains resourced to meet agreed scope of work.
    • Assess client business needs to identify gaps and non-compliance as well as general operational needs
    • Assist clients in the development and implementation of processes that support TMF management and inspection readiness
    • Create and update client SOPs that are in alignment with project activities
    • Lead team meetings as appropriate
    • Develop and deliver training as required by scope of project
    • Coordinate workload of team assigned to project

    Coordinate document quality review teams assigned to project

    Represent project system business needs within the scope of deliverables

    • Participate in system upgrade meetings to identify impact of upgrade deliverables on business activities
    • Communicate business needs to TMF Systems Manager

    Participate in Inspection Readiness reviews

    • Develop the TMF Inspection Readiness Plan
    • Work with the team to ensure reviews are performed in alignment with the Inspection Readiness Plan
    • Partner with the client to ensure that communications are seamless, and issues are resolved in a timely manner

Qualifications and Education Requirements

  • Minimum of 5 years of experience managing TMF activities to support multiple studies
  • Working knowledge of international regulatory record requirements and ethics requirements
  • Minimum of 2 years of experience in trial management with understanding of the drug development process
  • Bachelor’s Degree preferred in biological/health sciences
  • Knowledge of drug development process
  • Strong verbal and written communication skills, combined with computer experience including Microsoft Suite
  • History of providing quality customer service through collaboration, leadership, critical thinking, and innovation
  • Experience working is a variety of eTMF systems, mapping and resourcing skills are a plus

Just in Time GCP is recruiting for an individual with experience in reviewing, filing and QCing study related documents for inclusion in the TMF.  This role requires familiarity with documents spanning the Trial, Country, and Site levels.  Excellent attention to detail and process is  critical to your success as a QC Reviewer.  

This position is remote  based and requires less than 10% travel.

Role and responsibilities

  • Participates in the review of Records to ensure accuracy of TMF
  • Comply with requirement of GCP
  • Participate in uploading, reconciliation and remediation activities based on client conventions, procedures, and plans. 
  • Attend and engage in internal project team calls, communicate trends, gaps, and solutions.
  • Perform checks of QC reviews performed by others.

Qualifications and Education Requirements

  • Minimum of one (1) year of experience working with the TMF reference model
  • Minimum of 2 years’ experience working in trial management. 
  • Strong document identification knowledge and experience working in electronic TMF is preferred.
  • Excellent attention to detail 
  • Strong communication and computer skills

Just in Time GCP is recruiting for a Validation Manager.

The Validation Manager will lead the validation of eClinical Systems for Just in Time GCP clients as well as internal systems validation efforts. Supporting validation activities in accordance with FDA 21 CFR Part 11 and/or Eudralex Annex 11, the Validation Manager will develop and implement validation strategies to support the utilization of eClinical systems across a combination of system types, including eTMF, eISF and CTMS. The Validation Manager will serve as a Validation Subject Matter Expert (SME) both internally and for external clients, reviewing client system validation documentation and ensuring that change management and validation activities align with client Computer System Validation procedures.

This position is remote  based and requires less than 10% travel.

Role and responsibilities

  • Develop and implement eClinical systems validation strategies to support the utilization of eClinical systems in the execution and oversight of clinical trials across a combination of system types, including:
    • eTMF/eISF/CTMS
    • RIMS/RDMS
    • Direct Data Capture (DDC) and Electronic Data Capture (EDC)/eSource/eCOA/ePRO/eConsent
  • Lead validation projects for eClinical research systems
  • Serve as a validation Subject Matter Expert (SME)
  • Author client-specific and internal validation documentation
  • Evaluate new eClinical systems and platforms for FDA 21 CFR Part 11 and EudraLex Annex 11 compliance gaps
  • Lead execution of test protocols (IQ/OQ/PQ)
  • Support clients in UAT efforts
  • Perform software vendor audits
  • Identify opportunities for creating best practices in validation

Qualifications and Education Requirements

  • Minimum of 5 years’ experience in validation activities for one or more eClinical systems
  • Expert knowledge of FDA 21 CFR Part 11
  • Working knowledge of EU Eduralex Vol 4 Annex 11 a plus
  • Working knowledge of GCP/ICH and systems ethics requirements, including HIPAA and/or GDPR
  • Experience leading small teams
  • Bachelor’s Degree or other professional degree preferred
  • Knowledge of drug development process   Veeva Systems certification preferred

 This individual is responsible for management support of the Trial Master File, including start-up, health and completeness reviews, and close-out activities. This individual supports the client and internal team members to ensure quality deliverables through meetings, running metrics, trending issues and a variety of other responsibilities associated with the TMF.

Responsibilities

  • Coordinate the management of the Trial Master File for assigned studies.
  • Initiate start-up activities that support TMF management, including development of planning documents.
  • Maintain the overall health and completeness of the TMF.
  • Oversee and support TMF Quality Completeness Review processes to meet client and regulatory requirements.
  • Analyze trends, gaps and metrics to ensure proper escalation.
  • Engage in system implementations, upgrades and UAT.
  • Participate in internal and client meetings.

Qualifications and Education Requirements

  • Minimum of 2 years’ experience in trial management and the TMF Reference Model.
  • Knowledge of the drug development process.
  • Working knowledge of international regulatory and ethics requirements.
  • Experience working with a variety of electronic TMF systems and ability to learn new technologies.
  • Excellent attention to detail, organizational, time management and multi-tasking skills.
  • Bachelor’s degree preferred.