Senior Digital Health Technologies Specialist

The Senior Digital Health Technologies (DHT) Specialist is responsible for working directly with the DHT Manager to provide technical and general administrative support for assigned Digital Health Technology studies including but not limited to; managing and overseeing license agreements, supporting with managing translations, Confidentiality Disclosure Agreements (CDA), compliance monitoring, User Acceptance Testing (UAT) activities, including either direct participation in UAT execution or oversight of UAT activities, documentation management (IRB/EC & TMF) and study decommissioning. Possessing strong attention to detail, effective communication skills and robust organizational abilities, the Senior DHT Specialist will work collaboratively with other business units (e.g. Clinical Trial Management, Procurement, Legal, Finance), external vendors and Clinical Research Organizations (CROs) to ensure timely completion of all study related activities.

Job Duties

• Provides general day-to-day digital tool and technologies support working with vendors and internal cross functional teams
• Ensure smooth study operation with strong communication skills escalating any project operational risks to the DHT manager
• Reviews and monitors compliance for assigned studies, and escalates issues related to compliance to the DHT manager, contributes to compliance action plan development and implementation
• Drives UAT strategy, planning, execution, issues management and oversight by reviewing test plans, drafting UAT plans, scripts, and relevant documentation, directly participating in sponsor-level testing activities when applicable.
• Supports the DHT Manager, with digital tools and technology research to determine appropriate copyright holder of any COA instruments and establish licensing requirements
• Secure necessary Digital tool and technology permissions and license agreements (with the ability to review terms and conditions) to ensure alignment with new and/or updated license agreements through collaboration with.
• 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 and ensure payment of licensing invoices in coordination with internal functions..
• Support end to end translation process for supported digital tools and technologies.
• Track and maintain database of license holders, ensuring compliance with terms and conditions of relevant contracts
• Provide support for problem resolution between licensing holder and study team
• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
• Proactively recommends process improvement initiatives for the department
• May require up to 25% travel
  
  

Job Requirements

• General knowledge and awareness of systems development processes
• Ability to acquire working knowledge of copyright law and licensing/permission requirements for digital tools and technologies
• Effective verbal and written communication skills
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to proactively recognize project challenges, implement action plans, and escalate risks in a timely manner
• Strong organizational and attention to detail
• Ability to support and build collaborative relationships both internally and externally
• Basic familiarity of clinical drug development preferred
  
  

Minimum Years Of Experience

Bachelor's degree and minimum of 4+ years relevant industry experience.