Thermo Fisher Scientific

Essential Document Pack (EDP) Reviewer - Clinical Trials - FSP

Thermo Fisher Scientific • $93K — $125K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent experience in a related field.
  • 2+ years of clinical research experience with essential documentation.
  • Experience reviewing clinical trial documents for compliance and quality.
  • Proficient in SOPs and regulatory guidelines relevant to clinical trials.
  • Strong attention to detail and ability to identify documentation deficiencies.

Responsibilities

  • Review country-level essential documents for accuracy and compliance.
  • Assess site-level documents necessary for trial site activation.
  • Ensure all essential regulatory documents are complete and meet standards.
  • Identify and report documentation inconsistencies or deficiencies.
  • Communicate required corrections to EDP submitters and team members.
  • Re-evaluate revised documents to confirm corrections.
  • Track EDP review activities and outcomes accurately.

Benefits

  • Standard Monday to Friday work schedule.
  • Office-based work environment.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summary of Essential Functions:

Essential Document Pack (EDP) reviewer is responsible for the review and approval of the country and site essential documents. The EDP contains at a minimum the most critical essential documents required for site activation. The documents required to be collected for each study site/country will be documented in a study-specific Essential Document Compliance (EDC) Review Checklist. Once final study documents are available, the EDP is reviewed for all required essential regulatory documents for completeness, accuracy and quality. The packs are reviewed by designated EDP reviewers who are independent from the study.

Position Summary

The Essential Document Pack (EDP) Reviewer is responsible for the independent review of country- and site-level essential document packages required to support clinical trial site activation.

This is a hands-on clinical trial document review and compliance role. The EDP Reviewer assesses essential regulatory documents for completeness, accuracy, quality, and compliance with study-specific requirements, applicable SOPs, client requirements, and regulatory guidelines.

The strongest candidates will have direct experience reviewing clinical trial essential/regulatory documents, supporting study or site start-up, or working with regulatory documentation required for site activation.

Key Responsibilities
  • Independently review country-level essential documents for completeness, accuracy, quality, and compliance with the applicable Essential Document Compliance checklist.
  • Independently review site-level essential documents required for clinical trial site activation.
  • Confirm that required essential regulatory documentation is present and meets applicable study, sponsor, SOP, and regulatory requirements.
  • Identify documentation deficiencies, inconsistencies, missing information, or quality concerns.
  • Communicate review outcomes and required corrections to EDP submitters and/or appropriate study team members.
  • Review revised document packages to confirm identified deficiencies have been appropriately resolved.
  • Communicate final review outcomes to Study Start-Up Specialists and other applicable stakeholders.
  • Accurately track EDP review activities and outcomes in applicable systems and databases.
  • Maintain current knowledge of company SOPs, client SOPs and directives, study-specific requirements, and applicable regulatory guidelines.
  • Apply independent judgment when assessing whether clinical trial documentation meets established requirements.
  • Partner effectively with study teams to support timely and compliant site activation.


Minimum Qualifications
  • Bachelor's degree or equivalent combination of education and relevant experience.
  • 2+ years of relevant clinical research experience, including hands-on experience with clinical trial regulatory or essential documentation.
  • Experience reviewing clinical trial documentation for completeness, accuracy, quality, and/or regulatory compliance.
  • Experience in one or more of the following areas:
    • Clinical trial essential document review
    • Study or site start-up
    • Clinical regulatory documentation
    • Site activation
    • Regulatory start-up
    • TMF/eTMF or equivalent clinical trial documentation
  • Working knowledge of SOPs, clinical trial documentation requirements, and applicable regulatory guidelines.
  • Ability to independently identify documentation deficiencies and communicate required corrections.
  • Strong attention to detail, quality, and document accuracy.
  • Strong written and verbal English communication skills; local language proficiency where applicable.
  • Ability to work independently, exercise sound judgment, and manage multiple priorities and timelines.
  • Strong analytical, investigative, and problem-solving skills.
  • Proficiency with Microsoft Word, Excel, and PowerPoint, with the ability to learn new systems and technologies.

Preferred Experience
  • Experience working within a CRO, pharmaceutical, biotechnology, or other clinical research environment.
  • Experience supporting multinational or country-level clinical trial start-up activities.
  • Familiarity with global, regional, and country-specific clinical trial regulatory requirements.
  • Experience reviewing Essential Document Packages, regulatory document checklists, or equivalent site activation documentation.
  • Familiarity with ICH-GCP and clinical trial regulatory requirements.
  • Experience communicating document deficiencies and working with study teams to achieve compliant deliverables.


Compensation
The estimated annualized pay range for this position in North Carolina is $93,000.00-$125,000.00.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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