FSP TMF Operations Manager CSAR

Responsible for efficient and appropriate analysis of Trial Master Files (TMF) data and critical thinking to inform on trends and determine solutions. Have a quality mindset but be able to focus on supporting riskiest areas first. Work in a changing environment with evolving processes and changing priorities. Translate business needs into TMF process requirements.

Main Responsibilities include:

• Management and operational oversight of clinical trial platform technologies, specifically the Global Safety Notification Portal and TMF, including interaction with vendor and vendor oversight.
• Troubleshooting/problem solving of issues raised by business on systems and supporting processes, including escalation as required.
• Cross functional working (CSAR, DTI & Business).
• Assist with response to questions and findings from audits and inspections.
• Contribute to the continuous improvement of Clinical Systems & Analytical Reporting Manager (CSAR) and the wider Development organization through information sharing, training and education.
• Maintaining standard business processes within GDO Systems to ensure compliance to regulatory bodies.
• Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting GDO.

Independent Activities:

• Perform quality review of study TMFs focusing on TMF health indicators.
• Review data/reports to identify and highlight trending deficient areas, plan the prioritization and contact study teams.
• Respond to request for review of study’s TMF process related plans: E.g. TMF Management Plan, Study specific Index.
• Act as liaison for TMF transfers.

Study Team Interactions:

• Development and provision of monthly TMF health indicator-based dashboards to study teams and clinical program leads.
• Follow up on trending areas to establish and report back root cause.
• Drive study teams to plan actions and remediation.
• Escalate non-resolution of risky areas as relates to TMF.
• Contribute to audit/inspection needs as directed by TMF Ops Snr Mgr/Dir.
• Arrange kick-off calls for study start-up and closure, and facilitate ad hoc meetings with study manager/team.
• Address or triage study team TMF related questions.

Functional Team:

• Participate in review of TMF process and/or Veeva eTMF system enhancement.
• Feedback with ideas on the training roll-out.
• Provide feedback and share learnings: E.g. trends in quality findings, process suggestions, industry intelligence, re-training needs.

Ideal Background:

• Thorough knowledge of clinical Trial Master File process/activities, regulatory requirements and Good Clinical Practice.
• Advanced knowledge of clinical documentation and reporting.
• Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP).
• Good understanding of technical processes and PC environment including Microsoft suite of products.
• Knowledge of the national and international data protection legislation.
• Advanced ability 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.
• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities.
• Excellent communication, organization and tracking skills.
• Minimum 6 years of experience with document management systems and excellent understanding of system structures and generic document management functionality.

Education:

• Bachelor’s degree in life science/healthcare is required; with minimum 5 years’ experience in clinical development/clinical operations.
• Fluent written and oral English.

This role is not eligible for UK visa sponsorship.