TMF Manager - Top 5 Pharma

Discipline: Clinical Research
Job type: Permanent
Salary: £40,000 - £45,000 plus car allowance
Contact name: Joe Pearce

Contact email: joe.pearce@rbwconsulting.com
Contact phone: +44 1293 584 300
Job ref: 23769
Published: 14 days ago
Expiry date: 10 June 2022

TMF Manager – Top 5 Pharma – Remote or Hybrid - £40k to £45k plus car allowance

RBW Consulting are excited to announce an opportunity on behalf of our close client. This company are a global CRO with industry leading systems and site management tools. They are constantly adapting to make work more manageable, flexible, and efficient for their staff. This position will be sponsor-dedicated at a top 5 pharmaceutical company.

Job Purpose

Responsible for efficient and appropriate management of Trial Master Files (TMF) and other TMF related, inspection relevant documents from creation through archival in compliance with applicable SOPs, processes and study specific requirements for assigned trials according to established timelines.

Responsibilities

  • Run and lead eTMF activities.
  • Manage a team of highly skilled CTAs.
  • Provide oversight of eTMF activities outsourced to CRO Partners.
  • Partake in active vendor management, including development and monitoring of KPIs in respect of eTMF and document quality.
  • Work with the vendor to set up new studies.

Ideal Background:

  • Comprehensive understanding of TMF procedure, regulatory requirements and GCP
  • Extensive experience of clinical trial documentation and reporting
  • Good understanding of technical processes and PC environment including Microsoft suite of products
  • Understanding of the local and cross-national data protection legislation
  • Advanced capacity to work both independently and in matrix team setting
  • Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
  • Experience managing multiple tasks and projects within specified timelines and balance conflicting priorities
  • Excellent communication, organization and tracking skills
  • eTMF and paper filing experience

Benefits

  • Fully remote, flexible working
  • Consistent workload
  • Competitive salary: £40k - £45k plus car allowance
  • Work directly for a top 5 pharmaceutical company
  • Genuine career development opportunities

To apply:

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 1273 049 215

Please click ‘apply’ or contact Joe Pearce for any further information

About RBW Consulting

RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.

We are an equal opportunities Recruitment Business and Agency

RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.