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Associate Director HBS Compliance (Consent Codification)
AstraZeneca PLC Gaithersburg, MD
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Associate Director HBS Compliance (Consent Codification)

AstraZeneca PLC
Gaithersburg, MD
Expired: March 18, 2024 Applications are no longer accepted.
  • Full-Time

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. Tracking of HBS collected as part of AstraZeneca's clinical trials is a key pillar of compliance and an increasingly integrated field.As an expert, Associate Director HBS Compliance (Consent Codification) is responsible for driving the development, completeness, and quality of consent codification capabilities.The Associate Director HBS Compliance (Consent Codification) is expected to possess outstanding analytical and problem-solving skills, as well as proven relationship building and communication skills.

The role also requires experience in the review and interpretation of informed consent forms in clinical studies and strong IT skills particularly in the management of large data sets.Typical Accountabilities* Review the sample tracking, consent tracking and consent codification set up for each clinical study for quality and completeness, documenting the check and working with the vendor to resolve any observations.* Provide constant monitoring to drive and maintain consent tracking coverage against agreed targets.* Conduct regular reviews of consent codification data to ensure it conforms to agreed codification rules.* Act as AZ lead on the monitoring of sample tracking, consent tracking and consent codification set up activities, working with the vendor, clinical study teams and other key stakeholders to ensure availability of relevant resources including informed consent form templates.* Act as a subject matter expert for consent tracking and codification* Provide training support as required to stakeholders and bring updates to training materials and guidance documents where necessary* Work with stkaeholders to collect feedback, and work up new business case requirements to feed into development lifecycles* General support for exisiting 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* Manage end-user onboarding, training and communicationsEssential Requirements* Degree level education* Outstanding analytical and problem-solving skills involving large and complex data sets* Experience in pharmaceuticals and clinical research with knowledge of HBS regulations, laws and standards* Experience in review/interpretation of informed consent forms* Excellent written and oral communications skills* High ethical standards combined with attention to detail* Strong collaborative, partnering, and interpersonal skills* Strong ability to work independently* Willingness to take decisions* Fluent in English as the AstraZeneca working languageDesirable Requirements* Use of GlobalCODE or similar platforms* Experience of working with multiple stakeholders* Hands-on experience in collection, management and use of HBS as part of ongoing clinical trialsWhy AstraZeneca?At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.

There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.So, what's next?* Are you already imagining yourself joining our team?

Good, because we can't wait to hear from you.Where can I find out more?Follow AstraZeneca on LinkedIn AstraZeneca on Facebook AstraZeneca on Instagram Posted29-Feb-2024Closing Date14-Mar-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics.

We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.


AstraZeneca PLC

Gaithersburg, MD
20877 USA



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