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Trial Master File Associate Jobs in Connecticut (NOW HIRING)

Zwicker & Associates, P.C.

Associate Attorney

Enfield, CT

$80K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Draft, review, and file legal pleadings, motions, discovery, etc., in furtherance of active ... Minimum of one year of litigation/trial experience * Working knowledge of civil procedure * Debt ...

Zwicker & Associates, P.C.

Associate Attorney

Enfield, CT · On-site

$80K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Draft, review, and file legal pleadings, motions, discovery, etc., in furtherance of active ... Minimum of one year of litigation/trial experience * Working knowledge of civil procedure * Debt ...

Zwicker & Associates, P.C.

Associate Attorney

Enfield, CT · On-site

$80K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Draft, review, and file legal pleadings, motions, discovery, etc., in furtherance of active ... Minimum of one year of litigation/trial experience * Working knowledge of civil procedure * Debt ...

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Trial Master File Associate information

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

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What job categories do people searching Trial Master File Associate jobs in Connecticut look for?

The top searched job categories for Trial Master File Associate jobs in Connecticut are:

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Trial Master File Associate jobs near you
Infographic showing various Trial Master File Associate job openings in Connecticut as of August 2026, with employment types broken down into 70% Full Time, and 30% Contract. Highlights an 74% In-person, and 26% Remote job distribution.

Associate Director, Clinical Development Trial Lead (CDTL)

System One

Stamford, CT • On-site

$35.75 - $48.75/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Re-posted yesterday

Job description

Job Title: Associate Director, Clinical Development Trial Lead Location: Stamford, CT Type: Contract - 1 year Work Model: Onsite – onsite Joulé is partnering with a leading pharmaceutical organization seeking an experienced Associate Director, Clinical Development Trial Lead to drive the execution of complex global oncology clinical trials. This highly visible leadership role offers the opportunity to oversee study strategy, enrollment, budgets, CRO partnerships, and cross-functional teams while influencing clinical development decisions on a global scale.

Responsibilities

  • Independently lead the cross-functional study team in the development and execution of complex clinical trials and ensure delivery of clinical milestones on trial(s) with quality, on time, and within scope and budget.
  • Demonstrate independent leadership and influence when working with study teams, management, and business partners, and proactively identify issues and resolve them.
  • Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise to influence study design and program-level decisions considering regional needs.
  • Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial.
  • Coordinate and facilitate obtaining regional input to provide to the study teams.
  • Act as single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times.
  • Ensure inspection readiness of respective clinical trial(s), including timely documentation of deviations and creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics).
  • Report, manage, and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools.
  • Drive regional clinical operational processes and methodologies used.

Requirements

  • Bachelor's degree (scientific or health-related field preferred)
  • 5+ years clinical research experience or relevant experience in a scientific or health-related field
  • Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
  • Experience with oncology (early & late phase clinical trials)
  • Prior clinical trial site-level or affiliate experience
  • Prior experience with local/country regional requirements
  • Need to travel periodically to scientific/regional meetings

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M- #LI-MP1 Ref: #568-Clinical