Initially the SOLIS Global Clinical Solutions (GCS) manager will be responsible for the implementation of SOLIS in GCS and for provision of support and training of both CRO and GCS personnel on the new framework.

The successful candidate with have extensive networking, communication and stakeholder management skills liaising with groups both internal and external to AstraZeneca ensuring enterprise needs are met.  Internal stakeholders include: Science and Enabling Units IT, Business Development Operations BDO, Alliance Management and Alliance leads in specific functions, Clinical and Project Leadership in Biopharmaceutical and Oncology and across GCS. External stakeholders include preferred providers, potential partner company personnel, vendors and CROs

Strong organisational change management, influencing, communication and process adoption skills are a critical requirement, ensuring that projects are successfully implemented in a consistent manner.

Accountable for the effective and timely communication of information, and for the provision of high quality training for all new and updated processes, systems and central services in relation to SOLIS and GCS.

The SOLIS GCS Manager acts as primary escalation point for any SOLIS (outsourced sourcing strategy) relating questions and issues management related to GCS. He/she has a comprehensive understanding of the following:

• The SOLIS operational framework with respect to GCS roles and responsibilities, Description of Services, the Management and Oversight Plan associated with each service
• Comprehensive knowledge of interdependencies and integrations of AZ clinical trial systems involved in SOLIS
• GCS SOPs Guidance documents and training materials for AZ preferred partnership outsourced services e.g. IRT eCOA

In addition the SOLIS GCS Manager is responsible for the following

• Project Management of the Management and Oversight meetings as required
• Tracking, issues management, CAPA management, monitoring, trend analysis and oversight of quality across the CROs responsible for delivery of IRT and other AZ preferred services
• Responsible for creation and maintenance of SOLIS specific documentation
• Solutions advice for study teams
• Regular meeting management with CROs delivering AZ services - S/he leads and drives continuous improvement and innovation via industry-leading developments in line with the Development Operations business objectives

Essential qualifications:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
• Meaningful experience in clinical research with proper knowledge of clinical processes and systems
• Well developed project management skills.
• Vendor relationship and oversight experience, issue and risk management
• Understanding of outsourced operational model principles
• Ability to work and lead cross-functionally,
• Demonstrates good knowledge of GCP, AZ Procedural documents, as they pertain to study delivery systems and processes
• Good understanding of E2E patient and operational data flow in clinical systems, dependencies between clinical systems.
• Understand principles of Opertaional Due Diligence and vendor validation aspects
• Ability to work globally including international travel

Skills and Capabilities:

• Excellent negotiation, interpersonal, problem solving and conflict resolution skills
• Ability to works collaboratively, motivate and empower others to accomplish individual, team and organizational objectives
• Excellent verbal and written communication and presentation skills, with the ability to deal with ambiguity and create clarity
• Proactively identifies risks and issues and possible solutions
• Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
• Change management skills and championship of continuous improvement
• Conceptual, Analytical and Strategic thinking; concern for standards and willingness to learn from others
• Passion for customers, representing the needs of multiple customers in decision making process
• Comprehensive understanding of dynamics affecting the pharmaceutical industry and needs for transformation

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.