Compliance Specialist

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Introduction

Human Biological Samples (HBS) are fundamental to medical research in the discovery, development, and implementation of new treatments and diagnostics. HBS are ethically sensitive materials, and the collection, handling, and access to HBS are subject to strict regulations, principles, and ethical guidelines.

Reporting to a more senior HBS compliance professional, you will manage the technical aspects of global HBS projects and associated risks within the HBS Specialist area to deliver HBS compliance across AstraZeneca R&D in relation to programs involving the use of HBS. You will maintain administrative control procedures to ensure standards are adhered to and that elements of the compliance program are consistently applied. You may assist operational management with general compliance questions and ensure training is available locally where required. You may also benchmark other organizations in relation to compliance best practices. Increasingly, you will be encouraged to act independently or with minimal direction to manage and deliver high-quality project outputs. The role will also involve reviewing and interpreting informed consent forms in clinical studies, where experience would be beneficial. Strong IT skills, particularly in managing large data sets, are encouraged.

Accountabilities

• The Compliance Specialist (CS) will coordinate projects and assist in delivering an effective compliance program with respect to the use of HBS.
• Implement and maintain assigned elements of an effective HBS compliance framework.
• Conduct selected monitoring activities and provide operational/project support for auditing, investigations, assurance reporting, etc.
• Support operational implementation of AZ HBS quality framework and risk register.
• Manage collation and analysis of business information, consolidation, and maintenance of up-to-date documentation, frameworks/standards, and trainings.
• Support monitoring of progress of initiatives and workstreams through scorecards and metrics.
• Provide general support for existing sample tracking and codification operations, including but not limited to:
• Configuration and troubleshooting of data feeds (e.g., EDC and VCV) required by sample tracking and consent codification systems.
• Maintain study loading milestone records, with participation in regular study loading reviews with external vendors.
• Support end-user access management.
• Manage end-user onboarding, training, and communications.
• Work with stakeholders to collect feedback and develop new business case requirements as needed to feed into development lifecycles.

Essential Skills/Experience

• Bachelor’s degree level education
• Knowledge and understanding of compliance function, health care regulations, laws, and standards related to HBS
• Excellent analytical, written, and oral communication skills
• Demonstrable team working skills
• Ability to work independently
• High ethical standards, trustworthy, operating with absolute discretion

Desirable Skills/Experience

• Knowledge and understanding of compliance function, health care regulations, laws, and standards. Experience in pharmaceuticals or a related industry
• Use of GlobalCODE® or similar platforms
• Experience working with multiple partners
• Hands-on experience in the collection, management, and use of HBS
• Experience in review/interpretation of informed consent forms
• Experience in pharmaceuticals or a related industry
• 6 months of proven experience
• Project management experience and skills

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Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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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 authorisation and employment eligibility verification requirements.