Roche
Digital Biomarker Clinical Integration Manager
This job is now closed
Job Description
- Req#: 202310-122196
Execute our digital biomarker strategy to seamlessly integrate mobile sensor data workflows in the clinical development processes for customers with needs in areas of
Establish a trusted partner relationship with clinical trial customer teams - from pre-sales conversations on RIS Digital Biomarker products through to study protocol development, study setup and until close-out of the clinical trial engagement
Integrate, project manage and lead delivery of digital biomarker deployment in clinical trials with Roche Pharma and external customers
Drive the remote patient monitoring parts of IRB/Ethics Committee submissions and addressing follow up questions.
Develop translation, logistics, support and related processes, and select/manage vendors that provide these services at scale.
Prepare and manage distribution of site supporting materials, including trainings.
Provide operational support for digital biomarker solutions in studies, including by being the point of contact for support requests by physicians and study coordinators.
Create and maintain accurate study level progress information through the efficient use of systems, tools and reports.
Create and maintain centralized project/teamwork-spaces, including document creation and/or maintenance.
Ensure effective end-to-end communication and information sharing via compilation of study-specific documents and resources.
Establish and manage (matrix) teams of employees and additional contractors and consultants to deliver on your portfolio of clinical studies
Represent Roche Digital Biomarkers at conferences and industry events
University degree in Life Sciences or related field with a minimum of 5 years related experience in the pharmaceutical industry
Excellent knowledge of Digital Biomarker or eCOA deployment and operations in clinical drug trials.
Proven track record to guide diverse expert teams at the interface of clinical science, sensor technologies and informatics
Extensive experience in the area of sensor data and digital biomarker development.
Transparent communicator and able to apply effective empowering leadership
Proven experience with senior stakeholders in a broad range of even competing customer collaborations.
The Position
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.
You will be responsible to …
o Disease understanding
o Company internal drug decision-making (phase I-II)
o Regulatory treatment approval (phase III-IV)
Your profile:
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
About the company
606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.
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