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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
Our Clinical Consultants support our clients with both the TMF Services and Consulting units, acting as a Clinical and Process Optimization SME. A passion for driving compliant change is a key requirement.
This position is remote based and requires less than 20% travel.
Role and Responsibilities
- Develop, apply, and align best practice standards for processes based on an understanding of Clinical Operations, regulations, and guidance
- Perform Business Analysis consulting in the Clinical Domain by developing and implementing 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
- Direct Data Capture (DDC) and Electronic Data Capture (EDC)/eSource/eCOA/ePRO/eConsent
- Act as content Subject Matter Expert for technology implementation and content/data migration projects
- 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
- Participate in vendor relationship management activities
- Serve as a Subject Matter Expert (SME) on optimization, implementation, and maintenance of eClinical systems
- Collaborate with the Project Leads to ensure that project remains on schedule and within scope from a systems perspective
- Remain current on international Health Authority expectations related to eClinical systems and processes
Qualifications and Education Requirements
- 5+ years’ experience in Clinical Operations/Clinical Development and information management consulting experience
- Client engagement management and relationship building
- A keen, flexible and agressive intellect; superior conceptual thinking as well as analytical and problem solving skills
- Demonstrated ability to effectively collaborate with cross-functional virtual teams
- Experience working with applications for projects and Clinical activities (e.g. Veeva, Documentum, SharePoint, IMPACT, Medidata, etc.)
- Working knowledge of GCP and systems ethics requirements, including HIPAA and/or GDPR
- Strong communication skills, both verbal and written, at all levels
- Bachelor’s Degree
Preferred Skills
- Certification on leading R&D technology platforms is a plus, but not required
- Working knowledge of international regulatory record requirements and ethics requirements a plus
- Experience in providing consulting services
Project Management experience - Strong leadership skills
- Excellent computer skills including MSWord and MS Excel
The Systems Manager role includes analyzing, implementing, managing, networking and collaboration with internal and external clients to ensure quality deliverables throughout all phases of a clinical trial. Systems Managers are responsible for overseeing and leading groups of people and projects to met 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.
This position is remote based and requires less than 20% travel.
Role and responsibilities
Responsible for contributing to and implementing key services to our clients through systems knowledge, support, and integration.
- Develop and implement eClinical systems strategies to support the utilization of eClinical systems across a combination of system types, including but not limited to eTMF, eISF, RIMS, CTMS, EDC, eCOA/ePRO
- Oversee the stategy, management, and integration of an eClinical systems, including vendors and technology
- Ensure change management is performed in alliance with the client’s CSV requirement and GXP standards
- Create and provide user training
- Partner with stakeholders throughout full lifecycle of eClinical systems integration
- Provide ongoing management and functional oversight for all eClinical systems
- 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
- Support the development of systems metrics reporting
- Participate in vendor relationship management activities to support Systems efforts and strategies
- Ensure work activities performed are in compliance with requirement of Good Clinical Practice (GCP)
- May have supervisory responsibilities
Qualifications and Education Requirements
- Minimum 5 years’ experience in Management of one or more eClinical systems
- Excellent 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
- 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 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.
This individual is responsible for contributing to and implementing the corporate strategy and core values while serving as a Consultant and SME in supporting clients.
Responsibilities
- Act as Consultant and SME in supporting clients in preparation for potential health authority inspections
- Act as Consultant and SME in supporting projects related to TMF Remediation including:
- TMF systems health assessments
- TMF quality health assessment
- TMF system optimization and implementation
- Act as Consultant and SME in the development of processes that support TMF management and inspection readiness
- Assess client business needs to identify process gaps and non-compliance as well as general operational needs
- Provide services in managing clinical trials for clients including but not limited to:
- Develop clear and measurable trial management plans; define timelines, milestones, KPIs/metrics, project staff limitations and study site limitations
- Monitor status and timelines, and provide oversight and monthly metrics for activities performed by Contract Research Organizations and vendors
- Manage clinical trial, including deliverables from all functional areas and vendors in accordance with contractual timelines and sponsor specifications
- Provide oversight and/or facilitate development of trial documents such as the protocol, protocol amendments, informed consent forms, CMP, PD Plan, DMP, SAP, Manual of Procedures (as applicable), and site study binders including all required Sponsor Forms/Templates
- Set-up and facilitate central ethics committee submissions and approvals as required for multisite trials
- Coordinate and oversee training and monitoring activities of site monitors
- Oversee and possibly develop study training for staff, vendors, and sites
- Establish and oversee data review process including safety review and review of protocol deviations
- Organize and coordinate DSMB activities
- Oversee set-up and maintenance of the clinical trial Trial Master File to ensure it is maintained in a state of inspection readiness
Qualifications and Education Requirements
- Minimum of 8 years’ experience in trial management or clinical compliance
- Minimum of 3 years’ experience in TMF activities
- Experience with multiple clinical systems including TMF and CTMS
- Ability to align best practice with customer needs
- Working knowledge of international regulatory and ethics requirements.
- Change management experience
- Critical thinking skills with strong problem-solving skills
- Bachelor’s degree
Preferred Skills
- Experience in providing consulting services
- Project Management experience
- Experience working with a variety of TMF systems
- Strong leadership skills
The Inspection Readiness Manager role focuses on identifying GCP risks, gaps and inspection risks while reviewing the Trial Master File. Collaboration with the study team, Sponsor, CRO and sites are key to ensuring risks are mitigated, issues identified and resolved and the TMF and all involved are ready for inspection day.
This position is remote based and requires less than 10% travel.
Responsibilities
- Perform TMF Inspection Readiness (IR) Review of the TMF
- Provide IR team training related to the protocol and study plans
- Review source documents to identify potential inspection issues
- Identify and communicate TMF gaps and inspection risks
- Prepare summaries of review for client
- Provide oversight and guidance to appropriate party to ensure adequate resolution to identified issues
- Support clients during inspection activities
- Perform TMF Management activities, including the development of TMF Plans/Maps
- Conduct investigator site Health Authority inspection preparation visits
- Assist site(s) in remediating gaps
- Perform investigator site GCP audits, conduct practice interviews and provide coaching to site staff
- Provide support, direction and coaching to employees in the areas of GCP compliance
- Participate in the development of tools and methods for IR activities
Qualifications and Education Requirements
- Minimum of 5 years’ experience working in a GCP environment
- Knowledge of the drug development process.
- Extensive 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.
Just in Time GCP is recruiting for an individual with experience in reviewing trial master files and individual documents to join the teams as a TMF Specialist. This individual will assist with TMF Completeness reviews, uploading documents into eTMF, development of TMF plans/maps and resolving document queries.
This position is remote based and requires less than 10% travel.
Responsibilities
- Participate in TMF Records review.
- Participate in TMF Quality Completeness review, including generation of findings, identifying gaps, trends and query resolutions.
- Perform activities to support the set-up of the TMF
- Uploading of documents into the eTMF.
- Ensure work is performed in compliance with GCP requirements.
- Engage in internal and project team meetings.
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.
- Travel Required: Minimal
ROLE AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
- Lead and ensure that all project start-up actions are completed and tracked to ensure long term success of the project
- Interface with client to establish relationship and trust in relation to the project and scope of work
- Establish and maintain Risk, Action Items, Issues & Decisions (RAID) logs
- Ensure project resources align with scope of work and project deliverables
- Facilitate the development of client tools and templates
- Lead internal/external Kick-off meetings
- Drive project status communications for full project team
- Coordinate scheduling of client meetings, generation of agendas and meeting minutes
- Track timelines and deliverables and ensure that project remains on schedule and within scope
- Ensure resources are properly identified to meet scope of work and budget
- Manage project resource budget in alignment with Statement of Work for JiT
- Identify changes in scope of work and manage the Change Request processes and documentation, as needed
- Ensure that communications are seamless, and issues are resolved in a timely manner
- Prepare and present status reports to internal JiT and Client stakeholders, leveraging dashboards and metrics where appropriate
- Work with external partners and study team to address gaps, issues and mitigate risks.
- Manage interactions and relationships with third party vendors, as necessary
- Ensure all work activities are performed in compliance with requirements of Good Clinical Practice
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Minimum of 5 years of experience managing TMF activities to support multiple studies*
- Minimum of 5 years of experience in consulting or internal Sponsor project management
- Experience leading teams
- Excellent written and verbal communication skill
- Excellent problem-solving skills
- Excellent organizational, time management, and multi-tasking skills
- Excellent computer skills including MS Office & MS Project
- Excellent attention to detail
- Strong leadership skills
*Required for TMF Services PM roles only
