TMF Specialist in UK

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

Job Description

The TMF Specialist works closely with GCDO Business & Technology Capabilities colleagues to support cross functional clinical study teams to maintain a complete and contemporaneous and high quality TMF. The TMF Specialist demonstrates a good understanding of TMF processes and awareness of evolving regulatory requirements related to records management to support the development and delivery of TMF Operations strategy. The TMF Specialist support multiple TMF Operations activities and projects and will identify issues and escalate as needed to TMF Ops leads, promoting TMF inspection readiness and TMF best practices.

JOB DESCRIPTION:

• Perform Quality control activities process for TMF submissions to Veeva Vault (VV) eTMF in accordance with the documented process

• Carry out required activities in VV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process

• Carry out required activities in VV eTMF for all requests for changes to be made to TMF documents in accordance with the documented process

• Member of the TMF Ops team that oversees the TMF Ops mailbox for all new TMF specific questions and requests, ensuring all requests are triaged to appropriate TMF Ops team members

• Support the development of study-specific, cross-departmental TMF Plans and TMF Indexes

• Support TMF health activities at a global level including generating TMF-relevant metrics from the eTMF system and escalating as necessary

• Support the development and delivery of a high standard training for the eTMF system and documented TMF process

• Support TMF process improvement activities as required

• Promote the use of Sponsor eTMF with cross functional teams by building strong professional relationships and networks among peers and colleagues

• Support TMF Ops team activities in required TMF preparation for internal audits and/or Regulatory inspections

• Assist in mentoring and training of new staff and contractors as relevant to their role

• Support any other Business & Technology Capabilities project activities as required

MINIMUM REQUIREMENTS AND QUALIFICATIONS:

• Experience working in a TMF environment at a Sponsor or CRO company

• Current knowledge of Trial Master File Regulations and TMF Reference Model

• Previous experience working in an eTMF system (preferably Veeva Clinical Vault) as an end user, business, or system administrator

• Good communication skills

• Quality driven with a focus on attention to detail

• Flexible and adaptable to a fast-changing environment

• Good time management and organizational skills

• Good computer skills (Microsoft Office suite, SharePoint use)

• Ability to work independently and in a global team environment to support overarching TMF Ops team deliverables

• Educated to degree level or equivalent experience