Clinical Integration Manager

• Position
• Digital Biomarker Clinical Integration Manager
• Description

Digital health technology is transforming the way we develop personalised medicines for patients.

Roche is dedicated to creating community‑ and regulator‑accepted digital endpoints and digital outcomes that redefine how we measure disease progression in clinical drug trials, and make them accessible to Biopharma companies and the research community.

Job Mission

We, the Digital Biomarker (d BM) Chapter in Roche Information Solutions, are an integrated team of scientists, technologists, data analysts and operationalisation 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.

We are also establishing the scientific foundations for disease monitoring and screening solutions in clinical practice.

Responsibilities

• 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, set‑up 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 specialised 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 the assigned portfolio of clinical studies.

Qualifications

• 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 (e COA) 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.
• Equal Opportunity Statement

Roche is an Equal Opportunity Employer.

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