TMF Analyst

Job description

Your Responsibilities :
We are looking for an experienced TMF (Trial Master File) Analyst to join our team! As the TMF Analyst, you will consistently ensure that TMF is inspection ready and in alignment with the study agreed strategy and application milestones. Moreover, you will serve as point of contact for the study teams for TMF matters and liaise with TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure trial master files are inspection ready at all times.

Key Responsibilities:
• The TMF Analyst will ensure the clinical trial documentation is consistent with trial master file agreements and applicable SOPs, ICH GCP.
• Provision of project management expertise to Study Accountable Person (SAP) and their study team members globally as needed (e.g. instream quality check of trial master file data, drafting and preparation of documents etc.) to support their study deliverable targets, to agreed quality and data integrity standards.
• Conducting analysis and identification of business problems/opportunities that may arise and support the implementation of high quality solutions.
• Address requests in a timely and efficient manner.
• Assist in the development and delivery of training materials at the study level and provide subject matter expertise.
• Understand all technical aspects of Pharma TMF system and associated tools.
• Liaise with third party providers, performing as part of the cross-functional team.
• The TMF Analysts will be required to ensure that the documents are filed to meet the required timelines and the Analyst would ensure there is no deviation from the plan and follow up appropriately.
• The TMF Analyst would act as the expert and point of contact for any audit and inspections and assist with the development of correction action plans, if related to any findings.
• The TMF Analyst will monitor and identify trends for a study they support.
• The TMF Analyst will drive the TMF completeness metrics and track performance.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

The information that you have provided in your cover letter and CV will be used to assess your application.

Closing date for applications: COB – 4th of June 2019

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Thank you for your interest in this opportunity.

*LI-GSK

Why You?

Basic qualifications:
• Bachelor Degree or equivalent experience working in clinical research, clinical operations
• Knowledge and experience of using clinical trial master file (TMF) systems (paper or electronic) and associated business processes
• Knowledge of Trial Master File industry accepted standards, such as the DIA TMF Reference Model
• Knowledge of electronic document management applications (e.g., Documentum, SharePoint, Livelink)
• Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records
• Excellent interpersonal skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders
• Proven record of being customer driven and providing effective consultation and training
• Self-starter, able to work independently, as well in matrix team environment

Preferred qualifications:
• Analytical / logical, with superior attention to detail and an inclination to spot patterns and outliers.
• Be able to demonstrate a flexible, proactive, diligent and self-motivated approach to work

Why GSK? :
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

Contact information:
You may apply for this position online by selecting the Apply now button.

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