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 HR@justintimegcp.com with your resume and a note of interest for the position you are interested in.

Check back frequently as we are continually adding new opportunities as we expand. All positions are remote based.

To be eligible for consideration, candidates should be located in Pennsylvania, North Carolina, Kansas, Missouri, Florida, Indiana, Virginia, South Carolina, Texas, or New Jersey, Georgia, Massachusetts, New Hampshire, or Maryland.

Careers

Available Career Opportunities

Why choose Just in Time GCP as the next step in your career?

Just in Time GCP is a leading business and technology consulting firm specializing in clinical trial operations and Good Clinical Practice (GCP). Our dedicated team of experts is committed to driving innovation and excellence in clinical trials, helping our clients achieve their goals with cutting-edge solutions and unparalleled industry expertise.

We are seeking an experienced Director, Business & Technology Consulting to join our team. This role requires a dynamic individual with a strong background in clinical operations, extensive industry knowledge, and proven business development skills. The ideal candidate will balance business development and utilization targets, leveraging their network and expertise to drive growth and deliver exceptional consulting services.

What you will do – Highlights of Responsibilities include:

Consulting Expertise: Leverage 12+ years of experience in the clinical operations field to provide high-level consulting services to clients. Share your industry knowledge by participating in conferences, writing articles, and acting as a subject matter expert (SME).

Business Development: Utilize your experience in business development to identify and pursue new business opportunities. Build and maintain strong relationships with clients, partners, and industry stakeholders to expand our client base.

Industry Leadership: Act as a recognized industry SME, representing the company at conferences, webinars, and other professional events. Contribute thought leadership through publications and presentations.

Client Engagement: Meet a 50/50 split of business development and utilization targets. Work closely with clients to understand their needs, develop tailored solutions, and ensure successful project delivery.

Network Leverage: Utilize your existing network of connections within the industry to foster new business opportunities and partnerships.

Strategic Expertise: Provide strategic insights and recommendations on Trial Master File (TMF) strategy and other clinical operations technologies (QMS, LMS, CTMS). Lead the development and execution of Just in Time GCP strategies for new product offerings and technology integrations.

Team Management: Lead and manage a team of consultants, fostering a collaborative and high-performing work environment. Provide mentorship, support professional development, and ensure team alignment with company goals. 

To succeed in this position, the ideal candidate would have:

  1. Education/Experience: Undergraduate degree and minimum of 12 years’ experience in life sciences consulting or clinical operations required, or equivalent combination of education and experience; graduate degree preferred
  2. Consulting: Proven track record as a seasoned consultant with extensive industry knowledge.
  3. Business Development: Demonstrated success in business development roles, with a history of meeting or exceeding targets.
  4. Industry Presence: Active participation in industry conferences, publication of articles, and recognized SME status.
  5. Technology Expertise: Familiarity with TMF strategy, clinical operations, and related technologies such as QMS, LMS, and CTMS.
  6. Leadership: Strong leadership skills with experience managing and developing a team.
  7. Network: Extensive network of connections within the clinical operations and technology sectors.

The benefits of being part of the Just in Time GCP team

  1. This position is a virtual position.
  2. Competitive compensation package that recognizes your expertise and contributions.
  3. Enjoy flexibility in your schedule, promoting work-life balance. This includes Paid Time Off, paid holidays, winter break, and “half day Fridays” during the summer.
  4. A comprehensive range of healthcare options for you and your loved ones, including medical, dental, and vision plans (premium cost is shared between you and us), along with life insurance and short-term income replacement plans.
  5. Investment in your future financial well-being with a 401(k) savings plan including a company match.
  6. Collaboration with a vibrant, enthusiastic team of individuals who are passionate about what they do and who they work with.

To apply, send an email to HR@justintimegcp.com including your resume and the answers (1-2 sentences) to the questions below:

  1. How many years have you provided consulting services for clients?
  2. What industry conferences or events have you participated in as a speaker or panelist? Please list any articles or publications you have authored.
  3. How have you leveraged your professional network to create new business opportunities or partnerships in the past?
  4. Do you currently possess the legal right to work in the United States without requiring visa sponsorship now or in the future?
  5. In which state are you located?

To be eligible for consideration, candidates must be located in Pennsylvania, North Carolina, Kansas, Missouri, Florida, Indiana, Virginia, South Carolina, Texas, New Jersey, Georgia, Massachusetts, New Hampshire, or Maryland.

Just in Time GCP provides equal employment opportunities to all employees and qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other characteristic protected by law.

Why choose Just in Time GCP as the next step in your career?

Because we help organizations achieve operational excellence! Our team of professionals assist biotech and pharma companies develop and streamline compliant processes, proactively prepare for regulatory inspections, implement and optimize eClinical technologies, and provide an efficient and effective resourcing strategy for Sponsor oversight and TMF management. We take great pride in knowing that our GCP compliance support plays a role in helping clients achieve their goal of getting critical therapies to market and changing patients’ lives.

We are a fast-growing industry leader in the TMF (Trial Master File) Services, Inspection Readiness and Clinical Compliance (GCP) Consulting space. In fact, we have been recognized by INC500 for the past 3 years, as well as one of JP Morgan’s 50 Fast Growing Woman Owned/Led Businesses for the previous 2 years and most recently an INC500 Best Workplace. Our Founder & CEO was named EY Entrepreneur of The Year® 2022 Greater Philadelphia Award winner.

Are you looking to join an organization where you can make an immediate impact and champion the value of inspection readiness and GCP Compliance? Then you are ‘Just in Time’ to be a part of our amazing growth!

What you will do – Highlights of responsibilities include:

  • Supervises team of Records Associates and ensures quality standards of work product for team.
  • Assigns workload for Records Associates.
  • Proactively evaluates performance and provides guidance for professional development, recognizes achievements, and addresses areas needing improvement. Effectively resolves issues and conflicts.
  • Provides direction in alignment with the corporate strategy and core values.
  • Performs quality oversight reviews.
  • Identifies trends and issues of TMF record review.
  • Manages assignment of reconciliation and/or remediation work.

To succeed in this position, the ideal candidate would have:

  • Bachelor’s degree and a minimum of 3 years of related experience or equivalent combination of education and experience.
  • Strong proficiency in MS Office Suite.
  • Understanding of the TMF lifecycle and document management process (Paper/Electronic).
  • Proficiency working with a variety of eClinical systems and ability to learn new technologies.
  • Expert understanding of the TMF Reference Model structure.

The benefits of being part of the Just in Time GCP team

  • Virtual position.
  • Compensation package that recognizes your expertise and contributions.
  • Enjoy flexibility in your schedule, promoting work-life balance. This includes Paid Time Off, paid holidays, winter break, and “half day Fridays” during the summer.
  • Comprehensive range of healthcare options for you and your loved ones, including medical, dental, and vision plans (premium cost is shared between you and us), along with life insurance and short-term income replacement plans.
  • Investment in your future financial well-being with a 401(k) savings plan including a company match.
  • Collaboration with a vibrant, enthusiastic team of individuals who are passionate about what they do and who they work with.

To apply, send an email to HR@justintimegcp.com including your resume and answers to the questions below. Each answer should be brief with no more than 1-2 sentences.

  • What experience do you have with leading/managing a team?
  • Which eTMF systems you are familiar with?
  • Explain in your own words what the TMF Reference Model is and what zone you find most challenging.
  • Do you currently possess the legal right to work in the United States without requiring visa sponsorship now or in the future?
  • In which state are you located?

Just in Time GCP provides equal employment opportunities to all employees and qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other characteristic protected by law.

Why choose Just in Time GCP as the next step in your career??

Because we help organizations achieve operational excellence! Our team of professionals assist biotech and pharma companies develop and streamline compliant processes, proactively prepare for regulatory inspections, implement and optimize eClinical technologies, and provide an efficient and effective resourcing strategy for Sponsor oversight and TMF management. We take great pride in knowing that our GCP compliance support plays a role in helping clients achieve their goal of getting critical therapies to market and changing patients’ lives.

We are a fast-growing industry leader in the TMF (Trial Master File) Services, Inspection Readiness and Clinical Compliance (GCP) Consulting space. In fact, we have been recognized by INC500 for the past 3 years, as well as one of JP Morgan’s 50 Fast Growing Woman Owned/Led Businesses for the previous 2 years and most recently an INC500 Best Workplace. Our Founder & CEO was recently named EY Entrepreneur of The Year® 2022 Greater Philadelphia Award winner.

Are you looking to join an organization where you can make an immediate impact and champion the value of inspection readiness and GCP Compliance? Then you are ‘Just in Time’ to be a part of our amazing growth!

What you will do – Highlights of Responsibilities include:

  1. Lead projects related to GCP compliance, implementation of optimized Trial Master File oversight frameworks, Sponsor oversight gap assessment, process redesign & optimization, and inspection readiness
  2. Using your knowledge of clinical operations, perform gap assessments in both GCP compliance and operational efficiency to establish organizational current state
  3. Leverage your expertise in the drug development process and regulatory inspection trends/findings to help organizations develop the people, processes, and technology that drives GCP compliance and regulatory inspection preparation
  4. Leverage your understanding of applicable regulations and risk management to support organizations in right sizing and prioritizing their remediation of gap findings
  5. Develop and present training as required by project scope of work
  6. Participate in process mapping activities with clients to develop processes that are in alignment with client needs and remain compliant with GCP requirements
  7. Support the growth of company revenue and Consulting Services by leveraging your professional network and through attendance at national meetings, participating in sales calls, and developing proposals.
  8. Represent the company by presenting at webinars and national meetings
  9. Participating in internal process improvement efforts

 

To succeed in this position, the ideal candidate would have:

  1. Undergraduate degree and minimum of 12 years’ experience in life sciences consulting or clinical operations, or equivalent combination of education and experience; graduate degree preferred or equivalent combination of education and experience
  2. Experience leading teams and  developing staff
  3. Experience with global (domestic and international) regulatory and ethics requirements, and industry best practices
  4. Experience supporting risk-based Clinical Quality Assurance activities (e.g., risk assessment, GCP auditing, CAPA authoring/remediation)
  5. Experience with the drug development process and clinical trial conduct
  6. Experience supporting regulatory agency inspections
  7. Experience assessing cross-functional considerations in developing bespoke future state strategies
  8. Experience drafting procedures/QMS documents (e.g., Manuals, Policies, SOPs) and tools/guidelines/QRCs
  9. Experience preparing and finalizing presentations and/or visualizations that effectively tell a story, particularly as applied to client deliverables and project management
  10. Experience with client/account management and project management methodologies

The benefits of being part of the Just in Time GCP team

  1. This position is a virtual position.
  2. Competitive compensation package that recognizes your expertise and contributions.
  3. Enjoy flexibility in your schedule, promoting work-life balance. This includes Paid Time Off, paid holidays, winter break, and “half day Fridays” during the summer.
  4. A comprehensive range of healthcare options for you and your loved ones, including medical, dental, and vision plans (premium cost is shared between you and us), along with life insurance and short-term income replacement plans.
  5. Investment in your future financial well-being with a 401(k) savings plan including a company match.
  6. Collaboration with a vibrant, enthusiastic team of individuals who are passionate about what they do and who they work with.

To apply, send an email to HR@justintimegcp.com including your answers to the questions below:

  1. How many years of Clinical Research experience do you have?
  2. Different types of health authority inspections you have supported (i.e. FDA, MHRA, EMA, PMDA, etc)
  3. Which eTMF systems you are familiar with?
  4. Do you currently possess the legal right to work in the United States without requiring visa sponsorship now or in the future?
  5. In which state are you located?

To be eligible for consideration, candidates must be located in Pennsylvania, North Carolina, Kansas, Missouri, Florida, Indiana, Virginia, South Carolina, Texas, New Jersey, Georgia, Massachusetts, New Hampshire, or Maryland.

Just in Time GCP provides equal employment opportunities to all employees and qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other characteristic protected by law.

Why choose Just in Time GCP as the next step in your career??

Because we help organizations achieve operational excellence! Our team of professionals assist biotech and pharma companies develop and streamline compliant processes, proactively prepare for regulatory inspections, implement and optimize eClinical technologies, and provide an efficient and effective resourcing strategy for Sponsor oversight and TMF management. We take great pride in knowing that our GCP compliance support plays a role in helping clients achieve their goal of getting critical therapies to market and changing patients’ lives.

We are a fast-growing industry leader in the TMF (Trial Master File) Services, Inspection Readiness and Clinical Compliance (GCP) Consulting space. In fact, we have been recognized by INC500 for the past 3 years, as well as one of JP Morgan’s 50 Fast Growing Woman Owned/Led Businesses for the previous 2 years and most recently an INC500 Best Workplace. Our Founder & CEO was recently named EY Entrepreneur of The Year® 2022 Greater Philadelphia Award winner.

Are you looking to join an organization where you can make an immediate impact and champion the value of inspection readiness and GCP Compliance? Then you are ‘Just in Time’ to be a part of our amazing growth!

What you will do – Highlights of Responsibilities include:

  1. Participate in projects related to GCP compliance, implementation of optimized Trial Master File oversight frameworks, Sponsor oversight gap assessment, process redesign & optimization, and inspection readiness
  2. Using your knowledge of clinical operations, participate gap assessments in both GCP compliance and operational efficiency to establish organizational current state
  3. Leverage your knowledge of the drug development process and regulatory inspection trends/findings to help organizations develop the people, processes, and technology that drives GCP compliance and regulatory inspection preparation
  4. Leverage your understanding of applicable regulations and risk management to support organizations in right sizing and prioritizing their remediation of gap findings
  5. Develop training as required by project scope of work
  6. Participate in process mapping activities with clients to develop processes that are in alignment with client needs and remain compliant with GCP requirements
  7. Participating in internal process improvement efforts

 

To succeed in this position, the ideal candidate would have:

  1. Undergraduate degree and minimum of 7 years’ experience in life sciences consulting or clinical operations, or equivalent combination of education and experience; graduate degree preferred or equivalent combination of education and experience
  2. Experience with global (domestic and international) regulatory and ethics requirements, and industry best practices
  3. Experience supporting risk-based Clinical Quality Assurance activities (e.g., risk assessment, GCP auditing, CAPA authoring/remediation)
  4. Experience with the drug development process and clinical trial conduct
  5. Experience supporting regulatory agency inspections
  6. Experience drafting procedures/QMS documents (e.g., Manuals, Policies, SOPs) and tools/guidelines/QRCs
  7. Experience preparing presentations and/or visualizations that effectively tell a story, particularly as applied to client deliverables and project management

The benefits of being part of the Just in Time GCP team

  1. This position is a virtual position.
  2. Competitive compensation package that recognizes your expertise and contributions.
  3. Enjoy flexibility in your schedule, promoting work-life balance. This includes Paid Time Off, paid holidays, winter break, and “half day Fridays” during the summer.
  4. A comprehensive range of healthcare options for you and your loved ones, including medical, dental, and vision plans (premium cost is shared between you and us), along with life insurance and short-term income replacement plans.
  5. Investment in your future financial well-being with a 401(k) savings plan including a company match.
  6. Collaboration with a vibrant, enthusiastic team of individuals who are passionate about what they do and who they work with.

To apply, send an email to HR@justintimegcp.com including your answers to the questions below:

  1. How many years of Clinical Research experience do you have?
  2. Different types of health authority inspections you have supported (i.e. FDA, MHRA, EMA, PMDA, etc)
  3. Which eTMF systems you are familiar with?
  4. Do you currently possess the legal right to work in the United States without requiring visa sponsorship now or in the future?
  5. In which state are you located?

To be eligible for consideration, candidates must be located in Pennsylvania, North Carolina, Kansas, Missouri, Florida, Indiana, Virginia, South Carolina, Texas, New Jersey, Georgia, Massachusetts, New Hampshire, or Maryland.

Just in Time GCP provides equal employment opportunities to all employees and qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other characteristic protected by law.