Careers

Work With Us

Join Our Team

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.

Careers

Available Career Opportunities

Trial Master File (TMF) Records Supervisor

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 develop processes that are regulatory compliant, proactively ready for inspection and provide an efficient and effective resourcing strategy.

Just in Time GCP is a fast-growing industry leader in the TMF (Trial Master File) Services, Inspection Readiness and Clinical Consulting space. In fact, we are recognized in the top 1000 on the Inc. 5000 list of America’s Fast Growing Private Companies three years in a row as well as one of JP Morgan’s 50 Fast Growing Woman Owned/Led Businesses. You are ‘Just in Time’ to be a part of our amazing growth!

What you will do:

The Records Supervisor will supervise a team of Records Associates ensuring quality standards are met. The Records Supervisor reviews client Trial Master File (TMF) records and performs TMF remediation activities to ensure that the records meet client quality standards.

Supervises team of Records Associates and ensures quality standards of work product
Participates in the hiring, selection, and on-boarding process
Assigns workload for Records Associates
Proactively identifies knowledge gaps and develops staff competencies to address these gaps
Provides support and career development through positive environment
Performs quality oversight reviews of Records Associates
Participates in TMF Record Processing
Performs record quality checks based on client business documents and records standards
Performs review of record metadata to ensure it aligns with client business rules
Performs secondary quality checks of records and applies self-evident corrections as per client business rules
Ensure that documents have been categorized correctly and metadata has been assigned based on client processes and business rules
Updates completeness tool with 1572/DOA info
Uploads and classifies documents to the eTMF
Performs record quality checks prior to document upload based on client business documents and records standards
Assigns metadata based on client business standards
Identifies trends and issues of TMF record review

What’s in it for you:

Work where you want! We have a great office in Warrington PA, but you may like your kitchen table better or your back porch on the beach! You decide (we will even pay a portion of your internet service). We care more about results that scenery!
Competitive compensation packages that recognize your expertise and contributions to our growing business.
Flexible scheduling that encourages you to find your “balance”, including Paid Time Off, paid holidays and “half day Fridays” during the summer months.
A full menu of health care options for you and your loved ones, including medical, dental, and vision plans (premium cost is shared between you and us), as well as short-term income replacement plans for your peace of mind.
Investment in your future financial well-being with a retirement savings plan that includes a company match.
Work alongside a group of fun, dynamic, passionate people that love what they do and who they do it with.

If this sounds like you, what are you waiting for?

You could be Just in Time to start an incredible career journey.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

Up to 3 years’ experience working within Trial Master File
Previous management/supervisory experience preferred
Strong proficiency in MS Office Suite
Proficiency working with eClinical systems

CORE SKILLS AND KNOWLEDGE

Ability to work in a fast-paced environment and meet deadlines
Ability to drive collaboration and lead a team
Strong teamwork and interpersonal skills
Strong communication skills (written and verbal)
Strong attention to detail
Strong ability to apply business process rules to work activities and identify gaps in process impacting content review
Strong organizational skills and ability to complete tasks to deadlines independently

Senior Trial Master File (TMF) Manager

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

Just in Time GCP is a fast-growing industry leader in the TMF Services, Inspection Readiness and Clinical Consulting space. In fact, we are recognized in the top 1000 on the Inc. 5000 list of America’s Fast Growing Private Companies three years in a row as well as one of JP Morgan’s 50 Fast Growing Woman Owned/Led Businesses. You are ‘Just in Time’ to be a part of our amazing growth!

What you will do:

The Senior TMF Manager is responsible for the same activities as the TMF manager which includes conducting activities associated with maintaining the overall health and completeness of the Trial Master File (TMF). They lead a team of TMF professionals in conducting TMF reviews and oversight activities for clients. The Senior TMF Manager acts as TMF subject matter experts in managing the quality, completeness, TMF structure, TMF plans, inspection readiness, and compliance for TMF documentation. They provide training and support to staff, develop training materials for client projects, and lead remediation efforts. They provide expertise for the oversight and delivery activities associated with TMF health.

Leads and manages assigned team of staff in accordance with organization’s policies.
- Manages the hiring and selection process for a group of staff by conducting candidate review through participation in the interviewing and onboarding processes
- Plans, assigns, and directs work; appraises performance and guides professional development; rewards and disciplines employees; addresses employee relations issues and resolves problems
- Develops direct reports in alignment with the corporate strategy and core values
- Ensures that resourcing within line management aligns with corporate budget and corporate strategy
Communicates regular updates to JiT staff on all aspects of the projects assigned
Provides guidance, clarification, and strategy for regulatory requirements and compliance associated with TMF documentation
Provides expertise to teams in the filing of TMF documents as per the specific agreed upon study index based on the TMF reference model
Conducts reviews at Trial, Country, and Site level
Conducts full reviews, completeness checks, or risk-based reviews of documents with compliance to customer TMF plan, business rules and SOPs
Provides direction for TMF Management for assigned and ensures reviews are conducted in accordance with JiT quality standards
- Initiates start-up activities that support TMF management for all assigned studies
- Uses JiT templates to develop business documents that support TMF management activities
- Attends study team meetings ensuring that TMF gaps or quality issued are appropriately escalated within the team
- Maintains the overall health and completeness of the TMF for assigned studies
- Manages the TMF Quality Completeness Review for assigned studies
- Manages end of study eTMF activities, liaising with CRO partners to ensure compliance with SOPs and project timelines
- Supports inspection activities based on the needs of the client
Coordinates workload and assesses completed work of Staff assigned to the study

What’s in it for you:

Work where you want! We have a great office in Warrington PA, but you may like your kitchen table better or your back porch on the beach! You decide (we will even pay a portion of your internet service). We care more about results that scenery!
Competitive compensation packages that recognize your expertise and contributions to our growing business.
Flexible scheduling that encourages you to find your “balance”, including Paid Time Off, paid holidays and “half day Fridays” during the summer months.
A full menu of health care options for you and your loved ones, including medical, dental, and vision plans (premium cost is shared between you and us), as well as short-term and long-term income replacement plans for your peace of mind.
Investment in your future financial well-being with a retirement savings plan that includes a company match.
Work alongside a group of fun, dynamic, passionate people that love what they do and who they do it with.

If this sounds like you, what are you waiting for?

You could be Just in Time to start an incredible career journey.

QUALIFICATIONS AND REQUIRED EXPERIENCE / EDUCATION

Undergraduate degree and 5 years’ experience working with TMF
Experience with full TMF lifecycle document management experience
Experience with international regulatory record requirements and ethics requirements
Strong proficiency in MS Office Suite
Experience working with a variety of eClinical systems

CORE SKILLS AND KNOWLEDGE

Ability to drive collaboration and lead a team
Strong teamwork and interpersonal skills
Strong communication skills (written and verbal)
Strong attention to detail
Strong ability to apply business process rules to work activities and identify gaps in process impacting content review
Strong organizational skills and ability to complete tasks to deadlines independently
Good working knowledge of the TMF Reference Model Structure
Understanding of the dynamics between Sponsor and CRO
Understanding of Clinical Trial conduct, processes and functional groups involved in clinical trials
Understanding of ICH/GCP and other application regulations pertaining to TMF management for clinical trials and regulatory submissions
Strong organizational skills, problem-solving skills and critical thinking skills and ability to complete tasks to deadlines independently

Trial Master File (TMF) Manager

What you will do:

The TMF Manager is responsible for conducting activities associated with maintaining the overall health and completeness of the TMF. They act as TMF subject matter experts in managing the quality, completeness, TMF structure, TMF plans, inspection readiness, and compliance for TMF documentation. They provide training and support to staff, develop training materials for client projects, and lead remediation efforts. They provide expertise for the oversight and delivery activities associated with TMF health.

Communicates regular updates to JiT staff on all aspects of the projects assigned
Provides guidance, clarification, and strategy for regulatory requirements and compliance associated with TMF documentation
Provides expertise to teams in the filing of TMF documents as per the specific agreed upon study index based on the TMF reference model
Conducts reviews at Trial, Country, and Site level
Conducts full reviews, completeness checks, or risk-based reviews of documents with compliance to customer TMF plan, business rules and SOPs
Provides direction for TMF Management for assigned and ensures reviews are conducted in accordance with JiT quality standards
- Initiates start-up activities that support TMF management for all assigned studies
- Uses JiT templates to develop business documents that support TMF management activities
- Attends study team meetings ensuring that TMF gaps or quality issued are appropriately escalated within the team
- Maintains the overall health and completeness of the TMF for assigned studies
- Manages the TMF Quality Completeness Review for assigned studies
- Manages end of study eTMF activities, liaising with CRO partners to ensure compliance with SOPs and project timelines
- Supports inspection activities based on the needs of the client
- May serve as a Lead for TMF activities in preparation for regulatory inspections and audit.
Coordinates workload and assesses completed work of Staff assigned to the study

QUALIFICATIONS AND REQUIRED EXPERIENCE / EDUCATION

Undergraduate degree and 5 years’ experience working with TMF
Experience with full TMF lifecycle document management experience
Experience with international regulatory record requirements and ethics requirements
Strong proficiency in MS Office Suite
Experience working with a variety of eClinical systems

CORE SKILLS AND KNOWLEDGE

Ability to work in a fast-paced environment and meet deadlines
Ability to drive collaboration and lead a team
Strong teamwork and interpersonal skills
Strong communication skills (written and verbal)
Strong attention to detail
Strong ability to apply business process rules to work activities and identify gaps in process impacting content review
Strong organizational skills and ability to complete tasks to deadlines independently
Good working knowledge of the TMF Reference Model Structure
Understanding of the dynamics between Sponsor and CRO
Ability to provide quality customer service through collaboration and critical thinking
Understanding of Clinical Trial conduct, processes and functional groups involved in clinical trials
Understanding of ICH/GCP and other application regulations pertaining to TMF management for clinical trials and regulatory submissions
Strong organizational skills, problem-solving skills and critical thinking skills and ability to complete tasks to deadlines independently

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Records Associate II

ROLE AND RESPONSIBILITIES

Participates in TMF Record Processing
Uploads and classifies documents to the eTMF – Performs record quality checks prior to document upload based on client business documents and records standards and assigns metadata based on client business standards
Communicates trends and issues to the Supervisor
Participates in reconciliation and/or remediation work
Ensures all work activities are performed in compliance with requirements of Good Clinical Practice
Performs other activities as assigned

QUALIFICATIONS AND EDUCATION REQUIREMENTS

Minimum of 2 years’ experience processing documents into aTrial Master File
Knowledge of clinical study records
Strong proficiency in MS Office Suite
Experience working with eClinical systems
Understanding of the TMF Reference Model structure

Contracts and Budget Manager

What you will do

The Contracts & Budget Manager oversees contractual agreements, client related budgets and client invoicing. The position is critical to ensure the efficient management of contracts, budgets, and invoicing maintaining compliance with contractual obligations, optimizing financial performance, and mitigating financial risks.

· Manages the end-to-end contract lifecycle, including drafting, reviewing, and finalizing contracts with clients.

· Ensures compliance with contract terms, conditions, and legal requirements.

· Maintains a contract repository, ensuring accuracy and up-to-date records.

· Performs client invoicing as per contract.

· Conducts regular financial analysis to track project profitability and provides recommendations for cost optimization.

· Collaborates with Project Managers/Ops Leads and stakeholders to develop realistic and achievable budgets for projects.

· Collaborates with co-workers, clients, and vendors to address contractual and budgetary inquiries, resolve disputes, and ensure mutual understanding of financial obligations.

· Identifies and mitigates financial risks associated with contract negotiations, changes, and performance.

· Evaluates vendor proposals to ensure all requirements are
met.

· Prepares reports and/or special projects, which may include data collection, coordination, final copy preparation, distribution, etc.

· Manages budgets:

o Monitors invoices and budgets against contracts; identifies and communicates risks, under spend, overages, and trends to overages to Project Manager/Ops Lead and Leadership.

o Creates and/or reviews invoices for accuracy to SOW and ensures available funds remaining on purchase order

o Monitors accounts receivables, track timing of payments, monitor overdue invoices. Provides initial communication with clients on delays in receipt of payables.

· Establishes and maintains relationships with clients’ Accounts Payable organizations.

· Manages the GDPR Registry to ensure it is updated as client responsibilities change.

· Assist with special projects; design and produce complex documents, reports and presentations

QUALIFICATIONS AND EDUCATION REQUIREMENTS

· Undergraduate degree and 8 years of experience preferred or equivalent combination of education and experience.

· Thorough understanding of budgetary and financial principles, practices, and policies.

· Strong understanding of contractual terms and conditions, preferably within the pharmaceutical or life sciences sector.

· Excellent analytical skills with the ability to interpret financial data and provide meaningful insights.

· Proficiency in budget development, financial forecasting, and variance analysis.

· Familiarity with financial management systems and tools.

· Exceptional organizational skills and attention to detail.

· Effective communication and negotiation skills, with the ability to build positive relationships with stakeholders.

· Ability to work independently, prioritize tasks, and meet deadlines in a dynamic and fast-paced environment.

· Advanced proficiency in MS Office Suite (Excel Required)

CORE SKILLS AND KNOWLEDGE

· Ability to handle multiple tasks to meet deadlines in a fast-paced environment independently.

· Ability to balance project needs with deliverables through problem-solving skills and creativity.

· Ability to provide quality customer
service through collaboration, leadership and innovation.

· Ability to work effectively with roles/perspectives across all levels of organization.

· Strong teamwork, interpersonal and problem-solving skills.

· Strong communication skills (written and verbal).

· Strong critical thinking skills with excellent attention to detail.

· Strong organizational skills and detail oriented.

· Strong collaboration skills with team members