A new vision for healthcare. Where clinical research is a patient care option.
rare diseases • pulmonology • oncology • decentralized • decentralized trials
201 - 500
February 29
🇺🇸 United States – Remote
⏰ Full Time
🟡 Mid-level
🟠 Senior
👷♀️ Project & Program Management
🗽 H1B Visa Sponsor
A new vision for healthcare. Where clinical research is a patient care option.
rare diseases • pulmonology • oncology • decentralized • decentralized trials
201 - 500
• Serve as Care Access’ subject matter expert on global privacy requirements and compliance, including operational and technical implementation of privacy controls. • Advise Care Access on all aspects of compliance with HIPAA, GDPR, and the clinical research regulatory landscape. • Track and advise the company on emerging developments in artificial intelligence regulation. • Establish collaborative relationships across all business functions to implement and maintain robust privacy controls, including privacy by design and other key privacy principles, for a company engaging in global clinical research. • Advise Data Protection Officer on global data protection compliance & strategy. • Design and implement processes to ensure privacy impact assessments, data mapping, reporting, and other due diligence and compliance activities are timely and properly conducted. • Inform and support Care Access audit responses, RFPs and RFIs, and customer due diligence questionnaires. • Onboard, implement, and administer technical solutions to support the privacy program, including data mapping software. • Draft and negotiate privacy agreements, including but not limited to HIPAA Business Associate Agreements and international data transfer agreements. • Define and maintain privacy KPIs; report on trends to DPO; identify and implement necessary process changes. • Lead and collaborate with Information Security, IT, Clinical, Regulatory, and other groups to maintain and enforce proper controls and approvals are in place for all aspects of the privacy program. • Continuously develop and deploy effective strategies to strengthen efficiency, effectiveness, and compliance of the global privacy program. • Monitor inbound requests to ensure all inquiries are responded to in a timely manner and meet or exceed business requirements. • Project-manage privacy workstreams and initiatives. • Be an active and engaged member of the Care Access Legal team; support Legal team priorities and projects as needed.
• Bachelor’s degree and 6+ years’ experience implementing and advising on a global privacy compliance program. • 3+ years’ experience as a privacy expert in the healthcare/life sciences industry, strong preference for experience in clinical research and/or pharmaceutical sector. • Experience managing privacy risk on an international scale. • Expert knowledge of global data protection and artificial intelligence laws and regulatory developments, including but not limited to familiarity with US, Canadian, and European data protection standards. • In-depth knowledge of privacy and security regulations relevant to health data and clinical research, including but not limited to HIPAA. • Conversant in data security standards and risk management. • Ability to explain privacy principles in a crisp, clear way that is easy for non-experts to understand and apply. • Experience advising and presenting to all levels of corporate leadership. • Practical knowledge and experience interpreting privacy rules into pragmatic and actionable controls. • Positive, “how can I help?” mindset and self-driven commitment to excellent quality standards • Ability to track and remain current on all developments in relevant law and regulation. • CIPP certification(s) strongly preferred.
• PTO/vacation days, sick days, holidays. • 100% paid medical, dental, and vision insurance. 75% for dependents. • HSA plan • Short-term disability, long-term disability, and life insurance. • Culture of growth and equality • 401k retirement plan
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