Careers

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

Business Development

• Develop strong relationships with clients to generate new and/or add-on business for the future  
• Analyze business processes, propose solutions for current and future needs, and assist in implementing recommended improvements
• Provide information on the Company’s capabilities at conferences

Monitor system Key Performance Indicators (KPIs) to ensure that issues are promptly identified and communicated to the client

Escalate trends in issues within JiT

Participate in activities related to system implementation, upgrades and user acceptance testing

Ensure all work activities are performed in compliance with requirements of Good Clinical Practice

Participate in and lead (where appropriate) meetings: internal meetings, project meetings, and client meetings

Other activities as assigned

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 clinical trial management

Bachelor’s degree preferred in biological/health sciences

Knowledge of drug development process

Preferred Skills

Experience developing processes that support a variety of TMF systems and ability to learn new technologies with ease

Strong computer skills including Outlook, MS PowerPoint, MSWord and MS Excel

Ability to work in a collaborative environment

Proven leadership skills

Detail oriented

Strong process mapping skills

Strong critical thinking skills as demonstrated by providing innovative solutions to complex problems

Strong project management skills

Working knowledge of the drug development process

Experience with resourcing projects

Foster innovation and continuous improvement

Just in Time GCP is recruiting for an individual with experience in leading projects and teams to provide quality service as a TMF Manager.  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 others 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.
• Travel required: Less than 10%.

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.

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

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

Responsible for contributing to and implementing  key services to our clients through systems knowledge, support and integration. 

• Assure systems are properly implemented and operating to achieve and maintain GxP validation, including the review of validations documentation, testing and coordinating change management.
• Collaborate with user to establish operational workflows and create/provide user training.
• Develop electronic clinical systems strategy to support trial execution and oversight.
• Oversee strategy, management and integration of electronic TMF systems, including vendors and technology.
• Partner with stakeholders in defining business needs, project planning, vendor selections, development, deployment and end user adoption to provide ongoing management and functional oversight for all electronic clinical systems.
• Serve as Subject Matter Expert (SME) for clients and team for support, system and database asministration on the clinical database.
• Manage eTMF transfers and migrations in compliance with regulatory requirements
• Support the development of systems metrics reporting 

Qualifications and Education Requirements

• Minimum of 5 years’ experience in TMF Management
• Working knowledge of international regulatory record  and ethics requirements
• Experience leading small teams
• Experience working with a variety of TMF Systems
• Knowledge of drug development process
• Bachelor Degree or other professional degree preferred
• Systems certification preferred

The Systems Administrator will be responsible for supporting the Systems Manager and Project Leads with clinical systems administrative duties.

Role and Responsibilities

• Support system services for client including user access, review of validation documentation, training and Systems User Acceptance Testing execution
• Perform QC of configurations or other systems documents
• Provide support for projects to ensure that project remains on schedule and within scope
• Maintain Trackers
• eTMF Room Build and Study Set Up Form Reviews
• Other eTMF index and configuration verification tasks
• Contribute to the development of Just in Time GCP (JiT) best practices related to systems management
• Creation of Job Aids to assist users with clinical system tasks

Qualifications and Education Requirements

• Minimum of 2 years’ experience in TMF management
• Systems certification preferred
• Working knowledge of international regulatory records and ethics requirements
• Experience working in a variety of electronic TMF systems