ZipRecruiter

Log In

1

Trial Master File Associate Jobs in Connecticut (NOW HIRING)

Novotech

Clinical Lead

Brooklyn, CT · On-site

At least 5 years of experience as CRA (Clinical Research Associate) * Must have performed advanced ... Master's degree or higher level preferred Knowledge, Skills, and Abilities * Relevant knowledge and ...

eth

Associate Design Consultant

Danbury, CT

Maintain up-to-date files, filing, updating price page or follow-up correspondence. * Provide ... Update master and design center price pages and product books and samples. * Order memo fabric ...

eth

Associate Design Consultant

Danbury, CT · On-site

Maintain up-to-date files, filing, updating price page or follow-up correspondence. * Provide ... Update master and design center price pages and product books and samples. * Order memo fabric ...

Ethan Allen

Associate Design Consultant

Danbury, CT · On-site

Maintain up-to-date files, filing, updating price page or follow-up correspondence. * Provide ... Update master and design center price pages and product books and samples. * Order memo fabric ...

eth

Associate Design Consultant

Danbury, CT

Maintain up-to-date files, filing, updating price page or follow-up correspondence. * Provide ... Update master and design center price pages and product books and samples. * Order memo fabric ...

eth

Associate Design Consultant

Danbury, CT

Maintain up-to-date files, filing, updating price page or follow-up correspondence. * Provide ... Update master and design center price pages and product books and samples. * Order memo fabric ...

eth

Associate Design Consultant

Danbury, CT · On-site

Maintain up-to-date files, filing, updating price page or follow-up correspondence. * Provide ... Update master and design center price pages and product books and samples. * Order memo fabric ...

eth

Associate Design Consultant

Danbury, CT

Maintain up-to-date files, filing, updating price page or follow-up correspondence. * Provide ... Update master and design center price pages and product books and samples. * Order memo fabric ...

Reynolds + Rowella

Senior Tax Associate

Ridgefield, CT · On-site

$85K - $110K/yr

... accounting or Master's degree in accounting or taxation or related field • Minimum 5 year ... income tax filings; e.g., S-Corp, partnership, trust, individual • Understanding of and ...

Reynolds + Rowella

Senior Tax Associate

Ridgefield, CT · Hybrid

$85K - $110K/yr

... accounting or Master's degree in accounting or taxation or related field Minimum 5 year ... filings; e.g., S-Corp, partnership, trust, individual Understanding of and sensitivity to ...

previous page

Showing results 41-60

All JobsTrial Master File Associate JobsTrial Master File Associate Jobs in Connecticut

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.

What are popular job titles related to Trial Master File Associate jobs in Connecticut?

For Trial Master File Associate jobs in Connecticut, the most frequently searched job titles are:

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:

What cities in Connecticut are hiring for Trial Master File Associate jobs?

Cities in Connecticut with the most Trial Master File Associate job openings:

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.

Senior Regulatory Start Up Associate - Korean Speaking

Novotech

Brooklyn, CT • On-site

Full-time

Posted 5 days ago

Job description

The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, and, where applicable, throughout maintenance and close-out. They ensure that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals. 

Responsibilities:
Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects.
Provide expertise and guidance to RSM and/or PM on country and local  regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
Work within the scope of the Regulatory Start Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review 
Boards and other local bodies as appropriate.
 

Minimum Qualifications & Experience:

At least 3-5 years Regulatory Start Up experiences in clinical industry.
Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local  EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
Participate in company start-up initiatives, contributing to development and maintenance of Regulatory Start Up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements.
Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs.
Serve as the local subject matter expert on specialised aspects of regulatory and start up activities

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.  

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. 

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. 

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.


Novotech is a global full-service clinical Contract Research Organization (CRO).


At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. 


At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.


With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. 
At Novotech you will work alongside empowered teams with a shared commitment to success.

  • Strategic vs transactional mindset.
  • Ability to gain insights and make proactive decisions quickly.
  • Culture that fosters partnership and collaboration, where every voice is heard and valued.
  • Ongoing support from senior stakeholders and leadership team.
.

Apply