Digital Health Technologies Specialist
- United States
- Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
- ICON Strategic Solutions
- Remote
Senior Talent Acquisition Business Partner
- Icon Strategic Solutions
About the role
The Digital Health Technologies (DHT) Specialist is responsible for working directly with the DHT Senior Specialist and DHT Manager to assist in day-to-day support of DHT development such as obtaining license agreements, translations, Confidentiality Disclosure Agreements (CDA), monitoring compliance, supporting User Acceptance Testing (UAT), managing study documents, and supporting study decommissioning. The DHT Specialist must possess strong attention to detail, effective communication skills and robust organizational abilities to work collaboratively with other business units (e.g. Clinical Trial Management, Procurement, Legal, Finance), external vendors and Clinical Research Organizations (CROs).
What you will be doing:
- Assists in providing general day-to-day digital tool and technologies support working with vendors and internal cross functional teams
- Assists in reviews and monitors compliance for assigned studies, and escalates issues related to compliance to the DHT Manager or Senior Specialist,
- Participates in UAT strategy and execution by assisting in reviewing test plans, test scripts and conducting UAT under the guidance of the DHT Manager or Senior Specialist.
- Assists in the coordination, management, and reconciliation of study related digital tool and Technology documentation in the Trial Master File (TMF)
- Supports the DHT Manager or Senior Specialist, in researching digital tools and technologies to determine appropriate copyright holder of any COA instruments and establish licensing requirements
- Secure necessary digital tool and technology permissions, license agreements, and Confidential Disclosure Agreements (CDA) in collaboration with internal functions such as Legal, Procurement, Finance, and Patient Innovations. This includes tracking and maintaining the database of license holders, ensuring compliance with contract terms, and serving as the central point of contact for stakeholders.
- Monitor and communicate the status of licensing and contract agreements, assisting in problem resolution between license holders and the study team.
- Review and ensure payment of licensing invoices in coordination with the Clinical Study Lead and DHT Manager, and catalog source documents received from license holders and translation vendors.
- Secure necessary Digital tool and technology permissions and license agreements (including Master Service agreements, where appropriate) to ensure alignment with new and/or updated license agreements through collaboration with the following internal functions: Legal, Procurement, Health Economics & Outcomes Research, Finance, & Patient Innovations
- Track and communicate licensing and/or contract agreement status and serve as central point of contact for internal and external stakeholders for licensing and/or contract agreements in clinical trials
- Review licensing invoices for pass through costs in coordination with Clinical Study Lead and DHT Manager; and ensure payment of appropriate license fees is completed
- Secure, as necessary, Confidential Disclosure Agreements (CDA) with various Digital Health Technology vendors and license holders
- Receive and catalog source documents (English and translations) as received from the license holders and translation vendors
- Participates in supporting the end to end translation process for supported digital tools and technologies with oversight by a DHT Manager or Senior Specialist.
- Assist the DHT Senior Specialists with tracking and maintaining the database of license holders, ensuring compliance with terms and conditions of relevant contracts
- Provide support for problem resolution between licensing holder and study team
- May require up to 5% travel
You are:
- General knowledge and awareness of systems development lifecycle
- Strong verbal and written communication skills
- Ability to meet deadlines, manage time, and prioritize
- Strong organizational skills and attention to detail
- Ability to support and build collaborative relationships both internally and externally
- Basic familiarity of clinical drug development preferred
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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