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Trial Master File Intern - Fall 2024

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Medpace

20d ago

  • Internship
    Full-time
    Off-cycle Internship
  • Business, Operations & Strategy
  • Cincinnati

AI generated summary

  • You need attention to detail, organizational skills, and some document admin experience. Strong communication and MS Office skills required. Work 20-24 hours a week.
  • You will manage trial documentation, perform quality checks, communicate with global teams, and prepare documents for shipment in a computer-based and collaborative setting.

Requirements

  • High school diploma, or equivalent;
  • Some experience in document administration preferred;
  • High attention to detail;
  • Excellent organizational skills
  • Strong written and verbal communication skills;
  • Knowledge of MS Office
  • and experience with MS Excel is preferred;
  • Able to work a minimum of 20-24 hours a week.

Responsibilities

  • The TMF Intern supports TMF oversight for a trial by ensuring documents meet established quality standards. This position involves both independent and computer-based work, as well as opportunity for communication and collaboration with trial teams.
  • Manage electronic filing system for trial documentation;
  • Track, maintain, and perform quality check of electronic documents;
  • Communicate with internal associates globally regarding errors in trial documents; and
  • Prepare documents for shipment.

FAQs

What are the main responsibilities of a Trial Master File Intern?

As a Trial Master File Intern, your main responsibilities would include managing and maintaining the Trial Master File for ongoing clinical trials, organizing and filing essential documents, ensuring compliance with regulatory requirements, and supporting the clinical research team with documentation needs.

What skills and qualifications are required for this position?

We are looking for candidates who are detail-oriented, organized, and have strong communication skills. Prior experience in clinical research or a related field is preferred but not required. Proficiency in Microsoft Office applications is necessary, and familiarity with electronic Trial Master File systems is a plus.

Will I receive training and support during my internship?

Yes, you will receive training and support from our experienced team of administrators and clinical research professionals. You will have the opportunity to learn and grow in the role, gaining valuable experience in managing Trial Master Files for clinical trials.

Is this internship full-time or part-time?

We are offering both full-time and part-time positions for the Fall 2024 internship program. The schedule can be flexible to accommodate your availability.

How does this internship contribute to the overall success of clinical trials?

The Trial Master File is a critical component of clinical trials, as it ensures the integrity and quality of the data collected. By managing the Trial Master File effectively, you will be supporting the successful execution of clinical trials and ultimately helping new drugs or devices receive approval from regulatory bodies like the FDA.

Accelerating Drug, Biologic and Medical Device Clinical Development

Science & Healthcare
Industry
1001-5000
Employees
1992
Founded Year

Mission & Purpose

Medpace is a UK-based clinical research organisation (CRO) that specializes in providing comprehensive and tailored services to pharmaceutical and biotechnology companies. Their ultimate mission is to accelerate the development of life-saving and life-improving therapies through high-quality and efficient clinical trials. Medpace's purpose is to collaborate with their clients to bring innovative medical treatments to market by offering expertise in study design, regulatory support, site management, and data analysis. They aim to advance medical knowledge and improve patient outcomes while upholding the highest ethical and scientific standards in clinical research within the UK and globally.

Culture & Values

  • People

    People are what matter. Our employees are our most important asset, and we recognize the importance of rewarding them not only by providing the opportunity to make a real difference in the health and well-being of people around the globe, but also by recognizing a job well done and offering a place to grow and thrive.

  • Community

    We are committed to making a difference in the communities we operate in. We provide financial and volunteer support for a variety of nonprofit organizations worldwide with a focus on health and local community-related efforts. Year after year we contribute time and funding to various causes and charities in our worldwide communities.

  • Compliance

    Honesty, confidentiality, integrity, and adherence to Medpace policies, standard operating procedures (SOPs) and applicable regulatory guidelines are our governing principles. We believe in a culture of compliance and are committed to ethical and compliant business practices by maintaining the highest standards for business conduct.

Benefits

  • Flexible Work Environment

    Productivity meets flexibility. Remote work and flexible schedules (dependent on position level). Relaxed dress code with business casual attire when working on campus.

  • State-of-the-Art Offices

    Our modern, eco-friendly, Cincinnati-based HQ campus offers an on-site fitness center and fitness classes, IT Support “genius bar”, restaurants, bars, and more. Medpace has invested in global office infrastructure with comfort, convenience, and productivity in mind.

  • Workplace Journey

    Structured career paths, mentorship, and opportunities for internal growth make Medpace the ideal place to develop and advance.

  • Training and Development

    Medpace provides tools and internal training to help employees professionally develop and succeed.

  • All the Perks

    Employer-sponsored events, happy hours, holiday celebrations, activities, and employee discounts on local sporting events, fitness gyms and studios, attractions, services, and nearby small businesses are just a part of what is available.