Associate Director, Compliance Human Biological Samples
Qrios Minds AB / Biomedicinjobb / Göteborg
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hela Sverige About the position
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.
The HBS Compliance Associate Director is responsible for ensuring the compliant use of samples for research.
They are experienced in the review of informed consent and able to ensure samples are used in accordance with patient wishes, protecting our License to Operate.
They will ensure HBS Compliance procedures are followed with regard to HBS specific policies and standards, and can advise stakeholders on use of samples, including decision making on approval of requests for their use in research.
Responsibilities
Review and advise on use of HBS in accordance with patient consent.
Lead the identification and establishment of effective HBS compliance procedures to support review of samples as part of US inventories.
Manage HBS processes to ensure standards are adhered to and compliance requirements are consistently applied for use of HBS in research for samples in the US for the Amnesty project.
Support the business with compliant use of HBS through expert advice and decision making
Ensure risks arising from HBS due diligence activities for US Inventory are identified and recorded.
Maintain the documentation/SOPs associated with HBS due diligence activities for the US Amnesty project.
Monitor the effectiveness of HBS due diligence processes and identify opportunities for improvement.
Perform HBS due diligence reviews for AZ clinical sample use and re-use requests for HBS in the biobank to support delivery of timely and effective decisions.
Act as subject matter expert, reviewing informed consents and making recommendations on HBS use.
Your profile
Required Skills/ Experience/ Education/ Qualifications:
• Bsc. degree
• Experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS
• Experience in the review of ICFs regarding use of HBS and knowledge of HBS regulations, laws and standards
• Experience of working with multiple stakeholders while maintaining ethical standards and willingness to challenge inappropriate proposals/actions of senior leaders
• Experience in collection and use of HBS as part of ongoing clinical trials is desirable
• Previous experience as a process owner and process improvement is desirable
• Excellent analytical, written and oral communications skills
• Strong collaborative, partnering, and interpersonal skills
• Strong ability to work independently
• Willingness to take decisions
• Excellent knowledge of English, both written and spoken
About the organisation
This is a consultant assignment at AstraZeneca in Gothenburg for 12 months. During this time you will be hired by us at QRIOS.
QRIOS can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden's leading pharmaceutical and life science companies. So whether you're interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.
Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you're looking for a world of exciting assignments and new contacts, you'll like being a consultant.
About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world's leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Ersättning Fast lön
Så ansöker du Sista dag att ansöka är 2024-02-22
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "1014".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Qrios Minds AB (org.nr 556599-5999),
http://www.qrios.se/ Arbetsplats Qrios Life Science & Engineering AB
Kontakt Alma Foric
alma.foric@qrios.se 073-850 49 73 Jobbnummer 8468092
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