Manager, Global Clinical Solutions
4 weeks ago
**Manager, Global Clinical Solutions**
Global Clinical Solutions (GCS) drives the delivery of services and technology for AstraZeneca for its internal and external stakeholders.
The Manager, GCS supports teams to improve process effectiveness and performance in operational processes/procedures within the department, as well as providing support and guidance in the development of processes owned by Global Clinical Solutions.
OLOS is a role based in Global Clinical Solutions (GCS), that provides oversight of IRT (RTSM) and DPS systems in AZ outsourced studies. This role does not provide regular support on a study level (except validation, activities listed in eCOAPlus RACI), but is involved in oversight activities across the portfolio (both Late and Early phase studies). IRT (RTSM) and DPS study-level oversight is provided by AZ Study Oversight Lead.
As majority of system-related activities are delegated to a CRO, AZ as a sponsor of a study, remains accountable for the delivery of these responsibilities in accordance with all laws and regulations. Therefore, it is mandatory that AZ ensures oversight of tasks and activities that have been delegated to these clinical suppliers, and that quality has been maintained at all times.
**Typical accountabilities**:
In addition to existing oversight of a clinical supplier’s performance and quality at a portfolio level for Outsourcing (Outsourced Models and/or Preferred Suppliers) done by the Alliance Lead OR equivalent supported by Subject Matter Experts from business areas, OLOS will provide oversight of IRT and DPS-system-related items. The specific oversight details might vary per each CRO and would include (but not limited to):
- Being primary escalation point of contact for IRT (RTSM) and DPS (for scale and test/start solutions) Detailed escalation pathways are described in IRT (RTSM) escalation pathway document, located on R&D portal. DPS escalation pathway is currently being developed
- Oversight of CRO’s performance within IRT (RTSM) and DPS area (for SOLIS according to the RACI matrix, located on SOLIS R&D portal) in cooperation with Alliance Management
- Support with the creation & maintenance of SOLIS process documentation (ex. RACI matrix, guidance document, training slides)
- Providing advice for study teams (both within IRT (RTSM) and DPS) for scale solutions
- Support with the oversight of quality issues across the CROs responsible for delivery of IRT and DPS
- Ad-hoc support with IRT (RTSM) and DPS contracting of AZ-preferred vendors (for scale solutions)
- Review of final validation / User Acceptance Testing (UAT) documentation (risk-based approach to review) for scale solutions
**Education, qualifications, skills and experience**:
**Essential**:
- University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing, or equivalent experience
- previous experience in working with IRT and/or DPS systems
- ability to work collaboratively; proven organizational and analytical skills and proven skills to deliver to time, cost and quality
- good project management skills
- excellent knowledge of spoken and written English
- strong business communication, stakeholder management and presentation skills
- well-developed organizational and interpersonal skills
- ensures risks and issues management to ensure effective delivery. Expertly utilizes escalation routes and governance to gain traction and deliver rapid solutions
- shares lessons learned and best practice recommendations with relevant stakeholders to drive continuous improvement
- builds relationships and achieve results without line management input
- curious and self-motivated
**Desirable**:
- Expert in their relevant service
- experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
- some experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment
- experience in multiple fields of clinical development
- at least 2-year experience in Drug Development within a pharmaceutical or clinical background
- understanding ICH GCP guidelines in relation to study delivery
- experience of working in a global organization with complex/geographical context
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