Temp-Digital Health Technology Associate Manager

Digital Health Technology Associate Manager (R47373)

The Digital Health Technology Associate Manager (DHT AM) is accountable for the implementation of digital tools and technologies (e.g. electronic COA (eCOA), econsent, wearables, sensors, spirometry, ECG, etc.) in individual clinical research studies from study design to close out in collaboration with the study team. In this role, a typical day may include accountability for all supported digital tool and technology project timelines, translation, specifications, executing UAT, and ensuring collection of such data is in accordance with company/organisation Standard Operating Procedures (SOPs) and ICH/GCP.

This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight of DHT will vary accordingly. Responsible for enforcing digital tools and technology system standards, managing vendor performance, and supporting training & education of stakeholders.

• Responsible for the successful implementation of digital tools and technologies for one or more clinical research trials with quality and compliance
• Responsible for reviewing and approving project related DHT study documentation during the course of the project lifecycle
• Applies patient technology expertise on day-to-day activities and escalations
• Participates in cross-functional and departmental process improvements
• Communicates with internal and external stakeholders and escalates risks
• Provides input into protocol development as it relates to digital tools and technologies
• Acquires COA licenses, purchasing of digital tools and technologies, and associated translations
• Oversee vendor performance at the clinical trial level, performing root cause analysis and identifying corrective actions.
• Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to DHT:
• Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all supported technology systems related issues and end of study vendor deliverables
• Project documentation management
• Risk management planning
• Communication planning, information distribution, performance reporting, and project closure.
• Provides support for problem resolution between DHT vendors and company/organisation study team
• Collaborate with study team members on medical monitoring plan
• Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
• Monitor financial components related to DHT for each study
• Facilitates and contributes to study level lessons learned
• May require up to 25% travel

• Demonstrate knowledge of some digital tools and technologies. Specifically, eCOA systems development processes
• Demonstrated interpersonal & leadership skills
• Ability to understand the strategic direction and guidance for respective clinical studies
• A data driven approach to planning, executing, and problem solving
• Effective communication skills via verbal, written and presentation abilities
• Ability to independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to company/organisation and external vendors
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate
• An awareness of relevant industry trends
• Demonstrated vendor management experience
• Technical knowledge of trial management systems and Microsoft Project Server
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills, cross-functional team leadership and organizational skills

• A minimum of a Bachelors degree is required
• Minimum of 6 years of relevant industry experience