Trial Master File (TMF) Analyst

High Wycombe, England, United Kingdom

12/19/2024

Description:

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.

J&J IM Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.

Within Enabling Business Information Solutions (EBIS), the Clinical Trial Management Solutions business are 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!

Principal 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.