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- Tasks: Manage and maintain the Trial Master File, ensuring quality and compliance.
- 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 trials with real-world impact.
- Qualifications: Bachelor’s degree required; 3 years in pharma or clinical trials preferred, with tech skills.
- Other info: Diversity and inclusion are key; reasonable accommodations available for applicants.
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 #J-18808-Ljbffr
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
Familiarise yourself with the specific TMF systems mentioned in the job description, such as oneCTMS and iAware. Understanding how these systems work will not only help you during interviews but also demonstrate your proactive approach to learning.
✨Tip Number 2
Network with professionals in the clinical trial management field, especially those who have experience with TMF processes. Engaging with them on platforms like LinkedIn can provide insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends in automation technologies like RPA, AI, and ML. Being knowledgeable about these tools will position you as a forward-thinking candidate who can contribute to process improvements.
✨Tip Number 4
Prepare for potential interview questions by reviewing common scenarios related to TMF quality oversight and compliance. Think of examples from your past experiences that showcase your problem-solving skills and ability to drive change.
We think you need these skills to ace Trial Master File (TMF) Analyst
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in the pharmaceutical industry or clinical trials. Emphasise your technical expertise with electronic records systems and any familiarity with emerging technologies like RPA, AI, and ML.
Craft a Compelling Cover Letter: In your cover letter, express your passion for driving compliance and process improvement. Mention specific examples of how you've contributed to inspection readiness or quality oversight in previous roles.
Highlight Relevant Skills: Clearly outline your communication, problem-solving, and organisational skills in your application. These are crucial for the TMF Analyst role, so provide examples of how you've successfully led cross-functional teams or managed complex projects.
Showcase Your Understanding of TMF: Demonstrate your knowledge of Trial Master File content management and regulatory standards (ICH/GCP) in your application. This will show that you understand the importance of maintaining TMF quality and compliance.
How to prepare for a job interview at Johnson & Johnson
✨Understand the TMF Landscape
Make sure you have a solid grasp of what a Trial Master File is and its importance in clinical trials. Familiarise yourself with the key components, such as compliance standards and quality metrics, as this will show your commitment to the role.
✨Showcase Your Technical Skills
Highlight your experience with electronic records systems, particularly eTMF, and any familiarity with emerging technologies like RPA, AI, or ML. Be prepared to discuss specific tools you've used and how they can enhance TMF management.
✨Demonstrate Stakeholder Engagement
Prepare examples of how you've successfully collaborated with various stakeholders in previous roles. This could include training sessions, problem-solving initiatives, or process improvements that required cross-functional teamwork.
✨Prepare for Compliance Questions
Expect questions related to regulatory standards and inspection readiness. Brush up on ICH/GCP guidelines and be ready to discuss how you've ensured compliance in past projects, as this is crucial for the TMF Analyst position.
