Clinical Integration Manager
Role details
Job location
Tech stack
Job description
We are looking for a Clinical Integration Manager to lead the clinical integration of mobile sensor data workflows in clinical development processes, and lead delivery of digital biomarker clinical trials (from Phase 1 to Phase 4).
Job Mission
We, the Digital Biomarker (dBM) Chapter in Roche Information Solutions, are an integrated team of scientists, technologists, data analysts and operationalization experts, that leverages mobile technologies like smartphones and wearables to collect objective and continuous sensor data from patients in clinical trials.
We co-create innovative digital remote monitoring concepts for sensitive and meaningful drug development endpoints, implement them in technology solutions, develop health related outcome measures with the data, seek community- and regulatory acceptance of corresponding endpoints and offer them to Biopharma companies and research institutes for use in clinical trials. Moreover, we are establishing the scientific foundations for disease monitoring and screening solutions in clinical practice.
The Opportunity
- Execute the digital biomarker strategy to seamlessly integrate mobile sensor data workflows into clinical development processes for diverse customers.
- Establish trusted, long-term partner relationships with clinical trial customer teams from pre-sales conversations through to study protocol development, setup, and close-out.
- Integrate and project-manage the end-to-end delivery of digital biomarker tools and remote patient monitoring solutions in clinical trials with both internal and external partners.
- Drive the remote patient monitoring components of IRB/Ethics Committee submissions and effectively resolve follow-up regulatory queries.
- Develop translation, logistics, and support processes while selecting and managing specialized vendors to scale these services efficiently.
- Prepare and manage the distribution of site-supporting materials, delivering comprehensive onboarding and training to clinical sites.
- Provide operational support for digital biomarker solutions in ongoing studies, acting as the primary point of contact for physicians and study coordinators.
- Establish and lead cross-functional matrix teams of internal employees, contractors, and consultants to deliver on your assigned portfolio of clinical studies.
Requirements
- Education: University degree in Life Sciences, Informatics, or a closely related scientific/technical field.
- Experience: Minimum of 3 to 5 years of professional experience within the pharmaceutical industry or clinical operations.
- Domain Knowledge: Robust understanding of Digital Biomarker or electronic Clinical Outcome Assessment (eCOA) deployment and operations in clinical drug trials.
- Project Leadership: Proven track record managing complex project lifecycles, study deployments, timelines, and software maintenance budgets.
- Cross-Functional Collaboration: Strong capability to guide diverse expert teams at the intersection of clinical science, sensor technologies, and informatics.
- Stakeholder Management: Exceptional communication skills with a proven ability to influence without authority and manage relationships with senior stakeholders or competing collaborations.
- Leadership Style: Transparent communicator who applies empowering leadership principles to drive engagement and team success.
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