Clinical Supply Associate - Clinical Trials (Clinical Manufacturing & Supply )

Clinical Supply Associate

Location: Warsaw - hybrid work (3 days from the office, 2 days from home)

ABOUT ASTRAZENECA

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

SITE DESCRIPTION

Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you.

What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, lunch card, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), Multisport, anniversary awards, additional time off, pension plan, business travel insurance, recognition programme, flexible working hours.

At AstraZeneca, every one of our employees makes a difference to patient lives every day.

The Clinical Supply Associate (CSA) is the global entry level role working across various Clinical Manufacturing & Supply (CM&S) teams with task-based activities to ensure the delivery of clinical material and associated information to meet the agreed Clinical demand. The Clinical Supply Associate role covers parts of the clinical study lifespan, across all phases of the drug development lifecycle, covering small and large molecule drug products.

The CSA supports Global Clinical Supply Chain team with task-based activities that include, but not limited to:

• Manage Temperature Excursions.

• Manage the Pack Order Process.

• Manage Product Quality Complaints in the Events Quality Vault and sample returns

• Manage the Purchase Order process in the Coupa system to support projects, including interaction with external suppliers, and including co-ordinating delivery of some clinical materials through to GMP release.

• Perform IRT User Acceptance Testing e.g., IRT systems, SmartSupplies and other Enterprise systems

• Perform eTMF management tasks and QC checks

• Facilitate/ lead/support Continuous Improvement activities

• Provison of metric data, etc.

• Work in collaboration with and support Clinical Supply Program Leads, Study Leads, Planners and External Study Managers

• Deviation facilitation/leadership

• Design, maintain and document business sub-processes, including creation of Standard Work Instructions and SOP updates.

Typical Accountabilities (per AZ framework and regulatory expectations):

Safety, Health and Environment

• Contribute to improving SHE performance, proactively identifing SHE hazards and take appropriate actions

Compliance and Ethical Conduct

• Ensuring compliance of self and others to internal and external regulations

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

Delivery / Supply

• Ensuring customer service is always considered.

• On time, in full (OTIF) delivery of goods and services from external suppliers to underpin successful delivery of CM&S projects.

Cost

• Promoting a cost conscious environment to enable effective cost management.

Lean & Agile Culture / Standardised ways of working

• Ensure all work is carried out in accordance to approved and established processes and procedures.

Education, Qualifications, Skills and Experience:

Essential:

o University degree

o Knowledge of R&D supply chain and drug development process.

o Knowledge of Clinical Development processes relevant to investigational products.

Desirable:

o Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products.

o Understanding quality principles and GMP requirements

o Experience from purchase systems

o Experience from interfacing with external suppliers

o Understanding of Lean, Continuous Improvement and Business Process Management