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- Tasks: As a TMF Analyst, you'll manage and enhance the Trial Master File for clinical trials.
- Company: Join Johnson & Johnson, a leader in innovative medicine focused on improving lives.
- Benefits: Enjoy remote work options, a dynamic environment, and opportunities for professional growth.
- Why this job: Be part of a team driving compliance and innovation in clinical trial management.
- Qualifications: Bachelor's degree required; 3+ years in pharma or clinical trials preferred.
- Other info: We value diversity and provide accommodations for applicants with disabilities.
The predicted salary is between 36000 - 60000 £ per year.
Job Description – Trial Master File (TMF) Analyst (2406227097W)
Trial Master File (TMF) Analyst
At Johnson & Johnson Innovative Medicine (IM), what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Within Enabling Business Information Solutions (EBIS), the Clinical Trial Management Solutions business is recruiting for a Trial Master File (TMF) Analyst to join our Trial Master File (TMF) Center of Excellence (COE) team. The position may be located in the UK or India. Remote work options may be considered on a case-by-case basis and if approved by the company. As a TMF Analyst, you’ll act as the bridge between stakeholders, systems, and processes, ensuring the Trial Master File is maintained to the highest standards of quality and regulatory compliance. You\’ll be a key contributor to innovative solutions that enhance TMF management, support audits and inspections, and drive process improvement and automation.
If you thrive in a dynamic environment, have a passion for driving compliance, and are eager to contribute to inspection readiness, then please read further!
Responsibilities
- TMF System Management : Establish and maintain study-specific TMF structures, including study build, maintenance, lock/unlock, Expected Document List (EDL) templates, and placeholder management.
- Stakeholder Support : Enable TMF stakeholder engagement and innovation by providing expertise, training, and automation solutions to meet evolving business needs.
- System Integration : Collaborate with IT and system owners (e.g., oneCTMS, iAware, VIPER) to maintain system integrations and resolve related issues.
- Quality Oversight : Design, develop, and implement TMF quality and oversight reports/metrics, ensuring alignment with compliance standards and continuous improvement.
- Inspection Readiness : Support audits and inspections by maintaining system compliance and driving change management for process enhancements.
- Process Improvement : Identify and implement automation technologies (e.g., RPA, AI, ML) to enhance TMF quality, standardization, and operational efficiency.
- Collaboration : Work with TMF COE and Business Operations teams to identify areas for efficiency improvements, address user inquiries, and onboard new groups and departments.
- Filing and Data Management : Provide centralised TMF filing and data support to optimize processes and ensure consistency.
- Additional Tasks : Handle other TMF-related responsibilities as needed.
Key Relationships
- Internal : Collaborate with GCDO, EBIS, TMF COE, functional areas, strategic partnerships, BRQC, therapeutic areas (TAs), IT, and study teams.
- External : Coordinate with external vendors to support TMF processes and integrations.
Qualifications
Education and Experience Requirements
- Education : A bachelor’s degree is required, preferably in health, science, or information technology.
- Experience : At least 3 years in the pharmaceutical industry or clinical trials.
Candidates should have strong technical expertise, with proficiency in electronic records systems (particularly eTMF), IT tools, data warehouses, and, ideally, database administration. Familiarity with emerging technologies such as Robotic Process Automation (RPA), Machine Learning (ML), and Artificial Intelligence (AI) is a plus.
An understanding of TMF content management, clinical trial conduct, drug development processes, and regulatory standards (ICH/GCP) is advantageous. Experience with audits, inspections, and implementing quality metrics to support decision-making is highly desirable.
Good communication, problem-solving, and organizational skills are crucial, along with the ability to lead global, cross-functional teams and drive consistent business processes in diverse environments.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
Europe/Middle East/Africa-United Kingdom-England-High Wycombe
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Trial Master File (TMF) Analyst employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Trial Master File (TMF) Analyst
✨Tip Number 1
Familiarize yourself with the specific TMF systems mentioned in the job description, such as oneCTMS and iAware. Understanding how these systems work will give you an edge during interviews and show your proactive approach.
✨Tip Number 2
Highlight any experience you have with automation technologies like RPA, AI, or ML. Being able to discuss how you've implemented or worked with these technologies can set you apart from other candidates.
✨Tip Number 3
Prepare to discuss your experience with audits and inspections in detail. Be ready to share specific examples of how you've maintained compliance and contributed to inspection readiness in previous roles.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those who work with TMF processes. Engaging with others in the field can provide valuable insights and potentially lead to referrals for the position.
We think you need these skills to ace Trial Master File (TMF) Analyst
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a TMF Analyst. Familiarize yourself with TMF management, compliance standards, and the technologies mentioned in the job description.
Tailor Your CV: Customize your CV to highlight relevant experience in the pharmaceutical industry or clinical trials. Emphasize your technical expertise, especially with electronic records systems and any familiarity with RPA, ML, or AI.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for compliance and process improvement. Mention specific examples from your past experiences that demonstrate your ability to drive innovation and support audits.
Highlight Soft Skills: In your application, don't forget to mention your communication, problem-solving, and organizational skills. These are crucial for collaborating with cross-functional teams and managing stakeholder relationships effectively.
How to prepare for a job interview at Johnson & Johnson
✨Understand the TMF Landscape
Make sure you have a solid grasp of Trial Master File management, including its structure and regulatory requirements. Familiarize yourself with the specific systems mentioned in the job description, such as eTMF and oneCTMS, to demonstrate your technical expertise.
✨Showcase Your Experience
Prepare to discuss your previous experience in the pharmaceutical industry or clinical trials. Highlight specific projects where you contributed to TMF management, compliance, or process improvements, and be ready to explain how you overcame challenges.
✨Emphasize Collaboration Skills
Since the role involves working with various stakeholders, be prepared to share examples of how you've successfully collaborated with cross-functional teams. Discuss your approach to stakeholder engagement and how you’ve facilitated communication between different departments.
✨Demonstrate Problem-Solving Abilities
Be ready to provide examples of how you've identified issues within TMF processes and implemented solutions. Discuss any experience you have with automation technologies like RPA, AI, or ML, and how they can enhance TMF quality and efficiency.
