Senior Trial Master File Business Analyst

Edison, NJ


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We are currently searching for a skilled professional to join a well-known client’s team as a Senior Trial Master File (TMF) Business Analyst in Edison, New Jersey. The Senior (TMF) Business Analyst will execute the strategy of TMF Operations as it pertains to the electronic TMF system. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.


  • Electronic document management
  • Regularly trains others on TMF process and provides input on overall training strategy
  • Participate in policy and procedure development and defining processes around system usage
  • Conduct assessments of processes and data and detail the business and user requirements
  • Critically review and recommend changes to business processes 
  • Collaborate with application IT support, vendors, TMF Operations and cross functional teams 
  • Contribute to platform and technology strategy, creation of functional specifications, design specifications, and consult on conceptual design and prototype reviews
  • Create and maintain documentation (user manual, requirements, support, and release notes)


  • At least 4 years of experience in the pharmaceutical industry


  • Bachelor’s degree in relevant discipline, or equivalent years' experience

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.