TMF Lead, TMF Operations

at  Alexion PharmaceuticalsInc

POSITION SUMMARY

The TMF Lead within Global Study Enablement (GSE) is a key role for the execution of TMF processes and strategy within Alexion for both internal and external stakeholders in alignment with AZ Global Clinical Solutions (GCS) services and legacy study TMF management.
The TMF Lead will support implementation of TMF activities and processes for all assigned studies (Internal eTMF and CRO (Contract Research Organization) eTMF) in alignment with AZ processes and procedures and Alexion legacy processes as applicable. This role is expected to ensure ongoing awareness and compliance to KPI/Metrics and system data quality issues and work with study teams to support issue resolution and escalate non-compliance accordingly to ensure ongoing Inspection Readiness.
The TMF Lead, will be the TMF subject matter expertise (SME) and be the point of contact for assigned studies including studies utilizing CRO(s) to support on issues and on-going initiatives and escalate as needed.
The TMF Lead supports Alexion study teams in change management and adoption to ensure compliance to processes/procedures as well as providing support, input, training, and guidance in the development of clinical system processes led by AZVCV.

ESSENTIAL QUALIFICATIONS

• University degree in related discipline, preferably in biological science/life sciences or healthcare-related fields, such as medicine, nursing, or equivalent experience
• 2 + years’ experience with Trial Master File and eTMF systems
• At least 3 years’ experience in Drug Development within a pharmaceutical or clinical background
• Strong understanding of ICH GCP (Good Clinical Practice) guidelines
• Proven ability to multitasking, time management and have task-oriented performance
• Ability to work collaboratively across different regions and functions
• Strong business communication and presentation skills
• Innovative, Curious, and self-motivated
• Familiarity with Microsoft Office software including Word, Excel, Outlook, Visio, Project PowerPoint, Teams, PowerBI
• Knowledge/understanding of DIA TMF Reference Model
• Strong Knowledge of Good Document Practice requirements & ALCOAC + standards

PREFERRED QUALIFICATIONS

• Experience/Exposure to other Clinical Trial Management Systems (CTMS/EDC)
• Experience of using standard process improvement methodologies (e.g., Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
• Experience of working with various functional groups in a global organization with complex/geographical context
• Experience in Microsoft PowerBI/Excel
• Experience with Veeva Reports and Dashboards
• Experience in Teams Collaboration Tools such as Mural Board, Teams and Smartsheet
  AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

• Manage assigned study portfolio TMF related activities (Study Start up to Archive) across the portfolio and partnerships
• Ensure standards of TMF compliance (KPI/Metrics) are maintained across studies (Internal/External TMF)
• Assist with establishing and maintaining TMF monitoring and reporting
• Ensure notification of KPI/Metrics to study teams for ongoing awareness
• Identify trends across study teams/regions/therapeutic areas and support root cause strategies for resolution
• Attend and present at cross functional meetings as needed.
• Provides support to user communities (Internal/External) including:
• Conducting relevant process/system/tool trainings
• Facilitating knowledge sharing
• Establishing of best practice
• Ensuring communication with relevant stakeholders across GSE and AZ GCS Related to TMF and related systems
• Contributes to continuous improvement of processes and tools to define identify opportunities to improve efficiency/effectiveness of systems/methods/processes
• Prioritizes workload to achieve personal and work unit targets
• Participates in SME Workstreams as required
• Support with Audits/Inspections as needed
• Support integrations /acquisitions of TMF as needed
• Supports management of Paper TMF as required
• Supports management of ISF Retention and Destruction related requests
• Proactively stay current with best practices and recommends application across portfolio to continuously improve TMF operations processes
• Onboard/Mentor TMF peers as needed
• Other TMF related processes, system and support activities as required