Associate Dir. Clinical Operations, Process Expert (ADCO FPE)

This is what you will do:

The Associate Director, Functional Process Expert (AD FPE) will be directly reporting to Regional Director in AsiaPac to provide support and guidance to country teams in their region on procedural knowledge, process change management, and contribution to procedural training strategy and coordinating training activities addressing regional needs and gaps identified in the capabilities/skills of the country teams. At same time, the FPE will be closely working with Global Clinical Process Director (Senior Director, Country Operational Excellence) to provide functional governance and control of the assigned process.

The FPE represents COM in the AZ Process Network, is expected to speak on behalf of COM and the region. The Functional Process Expert (FPE) role is the key interface between AZ Business Process Owner (BPO)/ARDU Process Area Lead (PAL) and COM country teams, supporting high quality interactions and the central business process management team.

The FPEs and the the AZ BPO/ARDU PAL are responsible for implementing a process-centric culture to improve quality and efficiency. They support delivery of changes and improvements to the business processes and procedures which underpin our clinical trials including identifying and developing Key Performance Indicators (KPIs) to demonstrate process effectiveness.

The FPEs undertake activities across processes and mandatory procedural documents for which they are assigned.

The FPEs provide functional expertise (knowledge of the ways of working) for Standard Operating Procedures (SOPs), Work Instructions (WIs), Mandatory Templates & Forms, and Guidance Documents.

The FPE might be assigned as the owner to oversee and coordinate the work of SMEs that own internally managed, COM specific, Job Aids, User Manuals, Best Practices and Non-Mandatory Templates and Forms.

You will be responsible for:

FPEs should have broad knowledge and experience of the practical application of AZ and ARDU mandatory processes and procedural documents in their area (supported by SMEs as necessary), with a good knowledge of the Process for managing procedural documents and of the Clinical process Framework, so they can fulfil responsibilities across the key areas of activities related to document maintenance and development on behalf of their functional team:

• Functional representation during development of process changes and improvements: they provide functional inputs and leadership during process changes and improvements, ensuring documents meet the functional needs.
  They maintain a network of Subject Matter Experts (SMEs) to support process activities and the process network. FPEs in cooperation with COM Senior Director, Country Operational Excellence resolve any conflicting opinions between SMEs and stakeholders, explaining and justifying their functions requirements and perspectives within the process network.
• Partner with AZ BPMO and ARDU PAL network to support Process Adherence: Apply insights from process metrics to inform process and business improvement activities within their function. FPEs may be required to monitor and escalate KPIs that relate to their functions. FPEs will also participate in remediation of Quality incidents and subsequent CAPA (Corrective And Preventative Actions) resolutions, as necessary.
• Change agent: Support the effective uptake and adoption of new and changed processes including directing communication and engagement effort in the functions to the right user communities.
• First line of support for process users: Support functional process users by answering questions arising from the user community, primarily through osTicket and user forums.
• Process management activities for procedures internally owned by COM: in cooperation with COM Senior Director, Country Operational Excellence, COM SMEs and other COM stakeholders as applicable (e.g. RHCOs),
  • maintains working knowledge of, and monitors new or changes to current international regulations, legislation, guidelines, and/or industry best practices, and provides input to possible changes to internal processes or ways of working, especially in the areas related to investigational sites and monitoring
  • develops or oversees development of COM Procedural Documents that are compliant with global Procedural Documents and applicable international guidelines such as ICH GCP
  • in close cooperation with relevant partners, ensures excellence in the development and implementation of appropriate country operations-related processes, templates, guidelines, SOPs, tools and systems for successful clinical trial conduct; ensures compliance with ICH GCP and other applicable regulations (e.g. CFR) and requirements
  • provides operational leadership to the local implementation of systems and tools related to the delivery of clinical operational tasks or SOPs, ICH-GCP requirements, e.g. CTMS, eTMF, reporting tools and dashboards, etc.
• Contribution to creation and implementation of procedural training strategy for COM team
  • Implements COM training strategy and maintains training plans to support high performance delivery in coordination with COM Senior Director, Country Operational Excellence, RHCOs, and other relevant stakeholders, as appropriate
  • supports an effective training network within COM and relevant R&D functions, to leverage the mutual sharing of locally developed training materials

You will need to have:

• Sound knowledge of ICH-GCP and other relevant regulations. GCP and GDP expert, audit and inspection readiness, process management and continuous improvement
• Project Management including Risk and Change Management skills
• Understanding of quality by design, risk assessments, quality measures and metrics
• High attention to detail and accuracy
• Effective leadership skills including self-leadership and resilience, change enabling, training and workshop facilitation, learning agility, positive attitude in managing change
• Ability to collaborate with stakeholders in various functions, negotiation, influencing and communication skills with collaborative mindset, communicating with impact and delivering key messages, influencing without authority, active listening
• Good analytical, problem-solving and negotiation skills including tech savvy, logical and critical thinking, develop and execute solutions, strategic foresight and conceptual thinking
• High-level expertise in process governing COM activities and awareness or dependencies with processes owned by other functions, eagerness to continuously understand and expand this expertise and awareness
• Excellent communication skills; fluent oral and written English
• Positive attitude in managing change

Since the FPE speak on behalf of the function and receive all process questions from their function, it is strongly recommended the FPE is considered a Subject Matter Expert within their function and have the following experience in matrix and multi-disciplinary environments:

• Across multiple studies
• Across multiple roles
• Across multiple models

We would prefer for you to have:

• Experience leading operational excellence initiatives
• Experience in process improvement/management
• Cultural awareness
• Masters or Doctoral degree or equivalent in a scientific or business discipline

Qualifications:

• Bachelor’s Degree or equivalent in life sciences or similar scientific subject
• 7+ years’ experience in Clinical Operations, Compliance or Quality Management

Location : Seoul, South Korea or Taipei, Taiwan or Sydney, Australia or Istanbul, Türkiye

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.