Careers

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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.

Careers

Available Career Opportunities

This position requires a leadership team member that sets the strategy for the continued growth of JIT as a leader in TMF management and Clinical Operations. This position is remote based and reports directly to the CEO. 

Desired Profile 

• Contribute and implement corporate strategy, core values, and serve as a member of the leadership team.
Develop, apply and align standards for processes based on an understanding of Clinical Operations, regulations, and guidance.
• Ensure that client recommended processes are consistent with regulatory requirements, company process, and industry trends and standards.

• Drive innovation and the delivery of continuous process improvement, and industry trends and standards.
• Analyze business processes, propose solutions for current and future needs, and assist in the implementation of recommended improvements.
• Develop strong relationships with clients to generate new and/or add-on business for the future.
• Design and/or deliver consulting services, develop staff competencies, and proactively identify any knowledge gaps.
• Participate and lead internal client meetings.

Qualifications and Education Requirements

•  Minimum of 8 years’ experience in trial management
Minimum of 3 years’ experience in TMF activities                       
• Experience with multiple clinical systems including TMF and CTMS   
Working knowledge of international regulatory record and ethics requirements                                       
• Strong leadership skills                                                                       
Experience leading small teams                              
• Strong knowledge of drug development process                                                                 
• Excellent problem- solving skills
• Excellent written and verbal communication skills                                
• Travel Requirements: Less than 20%
• Bachelor’s Degree preferred

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