Trial Master File Study Owner

Job description

• Document Management and Quality
  • Remain familiar and up to date with relevant SOPs and processes for TMF document management.
  • Able to support internal colleagues and external study team members, signposting to relevant guidance.
• TMF Management
  • Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements.
  • Monitor milestones and events to ensure TMF Completeness via eTMF functionality.
  • Support development of the study-specific TMF Management Plan in collaboration with Study Team.
  • Support study team through closeout and archive preparations.
• TMF Metrics
  • Reviews metric report outputs with Study Teams on a recurring basis.
  • Deep dive of report outputs, identifying and sharing trends and risk areas.
  • Provide guidance on how to improve and maintain metrics.
• TMF Health
  • Support holistic quality review and perform spot-checks for quality oversight.
  • Provide TMF Health status updates to study team on a recurring basis, including verbal and/or written summaries.
  • Help facilitate, track and support periodic study team TMF reviews.
  • Maintain TMF Health oversight over the study lifecycle.
• Inspection Readiness
  • Manage remediation and retrospective reconciliation projects.
  • Manage ‘last minute’ inspection preparation activities.
  • Support Audits and Inspections.
  • Support implementation of CAPAs at study level.
  • Identify and escalate risks and trends impacting inspection readiness.
  • Develop proactive risk identification and escalation practices.
• Customer Relationships
  • Facilitate TMF-focussed communication and collaboration between Sponsor and CROs.
  • Communicate to the Study Manager (or equivalent) on all aspects of the TMF.
  • Build proactive relationships with the study teams, providing continued SME support.
• Training & Mentoring
  • Act as TMF SME, including related processes, to provide ongoing support to the Study Team.
  • Support development of internal and/or external TMF-related trainings.
  • Conduct training for Study Team and/or colleagues, either one to one or in a group setting.
  • Mentor staff in preceding roles and be point of contact for issue escalation. 

Requirements

• Communication, Collaboration, and Customer Service
  • Outstanding verbal and written communication skills combined with exceptional listening skills.
  • Committed team player, able to build effective working relationships with individuals at all levels of the organisation(s).
  • Ability to remain calm and focussed in high-stress situations with strong skills in negotiation and conflict resolution.
  • History of achievement in building strong customer relationships with demonstrated evidence of meeting customer needs and concerns through positive feedback.
• Clinical and TMF Expertise
  • Minimum of 5 years relevant experience in Clinical or TMF Operations oversight.
  • Thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
  • Experience in management of medical/clinical study records and documentation.
  • Experience or knowledge of Regulatory Agency inspection expectations.
  • Sound knowledge of ICH-GCP documentation requirements.
• Technical Expertise
  • Experience with the following application types:
  • Electronic Trial Master Files (eTMF)
  • Clinical trial management systems (CTMS)
  • Other clinical trial data or document management systems, as required
  • MS Office (Word, Excel)
  • Adept at learning and becoming proficient in new applications
  • Able to impart application knowledge to support and educate team members.

We offer

• Possibility of remote work
• LUXMED private medical care and the possibility of life insurance on preferential terms
• KAFETERIA benefit platform and Multisport card
• Employee Assistance Program (psychological and mentoring support available for employees and their families)
• Opportunities to develop qualifications through the 'Litmos' training platform
• Regular development conversations
• Additional days off and attractive jubilee gratuities
• Employee Referral reward
• Flexible working arrangements
• Integration events
• Great atmosphere & international environment