At a Glance
- Tasks: Lead TMF operations and ensure compliance across clinical studies while driving process excellence.
- Company: Join a leading organisation focused on clinical research and innovation.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to collaborate across various departments and external partners.
- Why this job: Make a significant impact in clinical operations and enhance your leadership skills.
- Qualifications: Bachelor's degree and experience in TMF management or clinical operations required.
The predicted salary is between 60000 - 80000 £ per year.
The Senior Manager, TMF Operations & Process Excellence serves as a key operational and process leader for the organization’s Trial Master File (TMF) and electronic Trial Master File (eTMF) ecosystem. The role acts as a strategic business partner across Clinical Operations, Clinical Development, Regulatory Affairs, Clinical Supply, Safety, Legal, Quality Assurance, Information Technology, and external partners.
This position is responsible for ensuring TMF processes, systems, and governance activities remain compliant, inspection-ready, efficient, and aligned with evolving business needs. It combines TMF expertise, eTMF system lifecycle management, process excellence, stakeholder engagement, training, inspection readiness, and continuous improvement.
Key Responsibilities- TMF Governance & Inspection Readiness
- Provide TMF governance support across clinical studies through training, consultation, TMF health monitoring, issue identification, and collaboration with study teams and CROs.
- Monitor TMF quality, completeness, timeliness, and inspection readiness.
- Use outputs from TMF reviews, audits, inspections, and metrics to identify risks, training needs, process gaps, and system enhancement opportunities.
- Partner with study teams and Quality Assurance to recommend risk mitigation strategies and support remediation.
- Support audit and inspection preparation and participate in inspections as needed.
- Promote TMF best practices and a culture of inspection readiness.
- Support development and maintenance of TMF plans, guidance documents, templates, and governance tools.
- eTMF System Lifecycle Management
- Support business ownership of the eTMF platform throughout its lifecycle.
- Coordinate change controls, enhancement requests, configuration updates, system releases, and business-driven improvements.
- Translate business requirements into effective technical solutions.
- Support impact assessments, UAT, implementation planning, deployment, and post-release monitoring.
- Participate in system governance and roadmap planning.
- Monitor system performance and user feedback.
- Manage issue resolution with internal and external stakeholders.
- Oversee configuration change management and user access governance, ensuring compliance with procedures and security principles.
- Process Excellence & Continuous Improvement
- Identify opportunities to improve TMF processes, workflows, controls, and user experience.
- Lead or support process improvement initiatives across development functions.
- Analyze operational trends, recurring issues, inspection observations, and stakeholder feedback to drive sustainable improvements.
- Develop practical solutions balancing compliance and operational efficiency.
- Support evolution of TMF governance frameworks and operating models.
- Documentation & Procedural Governance
- Author, review, and maintain SOPs, work instructions, guidance documents, templates, and training materials.
- Support implementation of procedural changes across functions.
- Ensure TMF and eTMF documentation remains current and aligned with regulatory expectations.
- Collaborate to simplify, harmonize, and standardize procedures.
- Stakeholder Management
- Serve as the primary TMF and eTMF subject matter expert.
- Partner with Clinical Operations, Clinical Development, Regulatory Affairs, Clinical Supply, Safety, Legal, Quality Assurance, IT, and external partners.
- Build strong relationships with study teams, functional leaders, CROs, and system vendors.
- Facilitate alignment across stakeholders with differing priorities.
- Gather feedback, identify root causes, and translate findings into actionable improvements.
- Represent business needs in system enhancement and governance discussions.
- Cross‑Functional Leadership
- Lead discussions on TMF processes, eTMF capabilities, inspection readiness, and operational challenges.
- Facilitate decision‑making while balancing compliance, business needs, user experience, and efficiency.
- Build consensus across internal and external stakeholders.
- Escalate significant risks and strategic considerations when appropriate.
- Act as a trusted advisor to study teams and functional stakeholders.
- Training & User Support
- Deliver training sessions for new and existing users.
- Develop role‑based training materials and guidance documents.
- Provide coaching and support to study teams and business stakeholders.
- Promote adoption of TMF best practices.
- Support onboarding related to TMF processes and systems.
- Maintain a library of role‑based training content and ensure updates following system or process changes.
- Plan and execute training rollouts for system enhancements and new features.
- Serve as the first point of escalation for eTMF technical issues, coordinating resolution with IT or vendors.
- Reporting & Metrics
- Define, build, and maintain a TMF metrics framework within the eTMF system.
- Produce and distribute regular TMF status reports.
- Use reporting outputs to identify patterns, elevate risks, and inform continuous improvement initiatives.
- Vendor & Partner Oversight
- Collaborate with external partners supporting the TMF ecosystem.
- Support governance meetings, operational reviews, and improvement initiatives.
- Track action items and ensure timely execution.
- Contribute to vendor performance monitoring and oversight.
- Bachelor’s degree in Life Sciences, Clinical Research, Quality, Information Systems, or related field.
- Significant experience in TMF management, eTMF operations, clinical operations, clinical development, quality assurance, or clinical systems.
- Experience with Veeva Vault eTMF or comparable platforms.
- Strong understanding of TMF requirements, inspection readiness, and TMF governance.
- Experience with system enhancements, releases, testing, and change management.
- Knowledge of GCP, ICH guidelines, TMF Reference Model, and regulatory requirements.
- Experience collaborating with CROs and cross‑functional stakeholders.
- Ability to manage multiple priorities in a dynamic environment.
- Experience managing user access in validated GxP systems.
- Experience building system‑generated reports and dashboards.
Senior Manager, TMF Operations & Process Excellence – 12 Month Contract – Exclusive employer: Planet Pharma
As a Senior Manager in TMF Operations & Process Excellence, you will thrive in a dynamic and collaborative environment that prioritises compliance and continuous improvement. Our company fosters a culture of innovation and professional growth, offering extensive training opportunities and the chance to work alongside industry leaders in a supportive setting. Located in a vibrant area, we provide a unique blend of work-life balance and access to cutting-edge resources, making us an exceptional employer for those seeking meaningful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, TMF Operations & Process Excellence – 12 Month Contract – Exclusive
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Planet Pharma.
We think you need these skills to ace Senior Manager, TMF Operations & Process Excellence – 12 Month Contract – Exclusive
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Planet Pharma.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Planet Pharma. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Planet Pharma
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Planet Pharma.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Planet Pharma achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
