Associate Director, System Owner

Introduction to role:

Global Clinical Solutions (GCS)

drives the delivery of Technology and associated processes for the

BioPharmaceuticals

R&D organisation, owning and providing industry leading technology and services on behalf of

Clinical

Operations and its internal and external Partnerships.

System Owner

is a member of Global Clinical Solutions Technologies (GCS Tech) department and is end-to-end accountable for the leadership, lifecycle

management

and continuous improvement of Clinical

Systems

.

System Owner works closely with vendor

s

, R&D IT (Information Technology), Functional Process Owners, Business Process Management Office (BPMO), internal and external

customers

and stakeholders to ensure customer needs are met and to enable

optimal

end-to-end delivery of clinical studies.

System Owner

is r

esponsible for

the identification,

definition

and delivery of improvements in end-to-end clinical study delivery, utilising

tools

and techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma).

System Owner

ensures that the System meets ICH/

GxP

requirements and aligns with industry direction, standards, and best practices.

The System Owner

represents

the business interests in strategy discussions and

provides

strategic advice to the Governance team in securing long-term business success of their assigned systems. Reviews and approves identified system risks and mitigations. Controls and prioritizes all business requests, such as those for feature enhancements, ensuring prioritization so resources (staff, vendor budget) are spent on value-add activities. Accountable for communication to key stakeholders and the business

regarding

the system (major incidents, new releases, etc.)

.

System Owner will lead and manage improvement projects as needed, and will contribute to functional,

regional

and global initiatives.

Accountabilities:

Design, development, implementation, maintenance, continuous

improvement

and ongoing customer support for the

allocated

systems

Accountable for lifecycle management of all procedural or system documents within the

allocated

area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies

Plans and prioritizes product feature backlog and development for the product

Defines system vision,

road-map

and growth opportunities

Researches and analyses the business context, the users, and the roadmap for the assigned system

Responsible to partner with and for providing leadership to service delivery teams within the given area.

Engage and influence internal and external key stakeholders to drive the strategy,

development

and continuous improvement within the given area.

Ensure customer requirements are understood, critically evaluated,

prioritised

and addressed within the given area.

Member of Operational Governance Teams relating to the given area

Responsible for monitoring performance of the assign

ed

system. Define,

track

and

monitor

key performance indicators and inform

improvement plans.

Support audit and regulatory inspection planning,

preparation

and conduct.

Understands the processes,

technology

and services the study team relies on, their needs and pain points. Uses this knowledge to supply advice and guidance, removes barriers, supplies

solutions

and finds opportunities for improvement.

Supplies guidance and

expertise

in the planning and delivery of system validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation.

Essential Skills/Experience:

Bachelor of Science (BSc) in a

life science or

computer science

,

or equivalent experience

Deep understanding of the

drug development

process, including clinical development

High

level

of business process,

technology

and Clinical Study information knowledge

Extensive experience

working with

computerized

system

s

i

n

a regula

ted environment

(

e.g.

GxP

).

E

xperience working successfully and collaboratively with external partners delivering mutual benefit

Proven ability

to deliver to time,

cost

and quality

Demonstrated excellent written and verbal communication