Manager, Global Clinical Solutions

Job Title: Manager Global Clinical Solutions

• Global Career Level:D

• Role Type:Individual Contributor

• Location:Bangalore India

• Work Type:Hybrid

• Total years of Exp:6-10 years

Introduction to Role:

Global Clinical Solutions (GCS) provides services and technology to support AstraZenecas Clinical Development programmes. It works with internal teams and external partners to deliver clinical studies on schedule within budget and to quality standards.

As Manager Global Clinical Solutions you will coordinate and lead the provision of services within GCS across clinical development projects and improvement will support teams in improving process efficiency operational performance and maintaining uninterrupted operations . You will also offer mentorship on developing implementing and maintaining workflows platforms and services owned by GCS.

In this role you will act as an AZ co-Project Manager for electronic Clinical Outcome Assessment (eCOA) and Digital Patient Solutions (DPS) activities. You will support setup maintenance and closure across clinical studies. You will work closely with study teams suppliers business analysts technology and quality collaborators to ensure that solutions remain aligned with the Clinical Study Plan user requirements and applicable quality and compliance requirements.

You will lead continuous improvement initiatives using structured methodologies. You will find opportunities to simplify and strengthen ways of working. You will support balanced adoption of changes across a global and geographically diverse organisation.

Accountabilities:

• GCS service delivery:Coordinate and deliver GCS services across projects and initiatives ensuring reliable operations and delivery within established timeframes budgets and quality standards.

• Lifecycle and business continuity management: Manage the lifecycle upkeep and continuous operational stability of GCS services systems processes and technology. Identify and reduce operational risks.

• eCOA and DPS project management:Serve as an AZ co-Project Manager for eCOA and DPS setup maintenance and closure activities managing plans timelines costs risks dependencies decisions UAT and stake-holder communications.

• Requirements and solution alignment:Coordinate input to eCOA and DPS user requirements from business analysts study teams and other stake-holders ensuring that solutions reflect the Clinical Study Protocol user needs and prior end-user experience.

• Supplier and collaborator coordination: Work with suppliers and cross-functional collaborators to agree appropriate system functionality resolve issues manage dependencies and maintain effective communication throughout the delivery lifecycle.

• System maintenance and change control:Lead operational maintenance activities to keep eCOA and DPS solutions aligned with current protocol requirements and in an appropriately validated state. Author and manage change requests including impact and risk assessments implementation tracking and closure.

• User Acceptance Testing:Establish and coordinate suitable UAT approaches for setup and maintenance activities including the mobilisation of UAT resources and guidance on test scripts plans reports defect management and change-closure documentation.

• Process and tool analysis:Analyse processes systems and tools to understand business usage and find opportunities to improve efficiency effectiveness user experience resilience and business continuity.

• Continuous improvement leadership:Lead or manage business improvement projects using Lean Lean Six Sigma or other appropriate methodologies from opportunity definition and root-cause analysis through to implementation and benefits tracking.

• Change implementation and adoption:Support the implementation of process system and service changes across functions and teams ensuring stake-holder readiness effective communication training adoption and sustainability.

• Performance risk and issue management: Evaluate service and programme performance. Monitor progress against agreed outcomes. Proactively manage risks issues and dependencies. Use appropriate governance and routes for critical issues.

• Capability building and knowledge management:Train colleagues in continuous improvement and relevant processes systems and tools. Capture lessons learned guidelines and outcomes to inform future initiatives and strengthen organisational capability.
  

Essential Skills and Experience

• Relevant academic or professional background: University degree in a related field. Preferably biological science healthcare medicine nursing life sciences or a similar area. Equivalent relevant experience may also be considered.

• Clinical or pharmaceutical experience:Relevant experience in pharmaceutical clinical development healthcare clinical technology or a related operational environment.

• Project and delivery management:Proven experience coordinating projects services or operational activities and delivering outcomes to agreed time cost and quality expectations.

• Analytical and problem-solving capability:Strong organisational analytical and problem-solving skills with the ability to evaluate complex processes identify root causes and develop practical solutions.

• Stake-holder and communication skills:Strong business communication presentation and stakeholder-management skills with the ability to work effectively across functions cultures geographies and organisational levels.

• Risk issue and governance management: Demonstrated ability to identify and manage risks issues and dependencies. Effectively handle customer concerns and secure timely decisions through accurate governance.

• Collaboration and influencing:Ability to build relationships influence stake-holders and achieve results without direct line-management responsibility.

• English language proficiency:Excellent spoken and written English with the ability to communicate complex information clearly to a range of audiences.

• Personal effectiveness:Curious self-motivated and adaptable with a strong commitment to quality compliance patient focus and continuous improvement.

Desirable Skills and Experience

• eCOA and Digital Patient Solutions:Experience with eCOA Digital Patient Solutions digital clinical technologies or another relevant GCS service area.

• Process improvement methodologies:Experience applying Lean Lean Six Sigma or other structured process improvement methodologies to identify root causes reduce process variation and improve operational performance.

• Clinical systems and validation:Experience with User Acceptance Testing requirements management supplier coordination system maintenance change control or validated systems.

• Quality management:Experience with Quality Systems and Quality Management including process definition risk assessment change management and process improvement ideally within an information systems environment.

• Clinical development and GCP:Experience across multiple areas of clinical development and an understanding of ICH GCP principles as they relate to clinical study delivery.

• Global operating environment:Experience working in a global organisation with complex geographical functional and stake-holder structures.
  

Why AstraZeneca

At AstraZeneca your work directly impacts patients while allowing you to grow alongside experts who blend science technology and innovation. You will collaborate across clinical data technology and operations functions to improve how studies are conducted from evidence generation to successful product delivery.

We value ambition curiosity and collaboration fostering a culture where people are empowered to take informed risks learn quickly and scale successful solutions. Diverse perspectives and cross-functional teamwork enable us to transform bold ideas into practical outcomes that advance medicine and careers.

Call to Action

Own this opportunity to elevate how clinical development operates at scale and help accelerate the delivery of better medicines to patients worldwide.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

Date Posted

Closing Date

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.