Digital Health Technologist

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Advanced Software Talent
clinical trials, Experience in medical device engineering, Data Analytics
Contract W2, 36 Months
Depends on Experience
Work from home available

Job Description

Direct W2 employees only!

No 3rd party agencies!

Start Date: Late October 2022

Digital Health Technologist - Contractor Position

This group is informatics for the early clinical development group which is part of  gRed. 

This is a new group at the client that only has a small team.

The goal of the group is to develop mostly wearable tools to sense biomarkers during clinical trials.

The group works with software engineering on some projects and has a number of vendors they

will partner with. 

Similar to  an ECG cardio monitoring device. It also could be recording devices for audio biomarkers.

This is an innovator job with not clearly defined boundaries.

This is a new group—so far there are two other people in Digital Technology for  Early clinical development.

The product is wearable tools to support clinical trials during drug development. 

Ideal candidate has experience in medical device development that has gone through the clinical trial process and validation of a medical device.  Knowledge of the Phase I-II drug development process is also a plus since they are supporting the clinical trial process.

Drug validation process is a plus.  Validation of a digital health device like Fitbit would also work.

This is a 3 year assignment. It could become full time.  They have approval for two contractor openings but whether they fill one or two no

Fully remote is fine.  Local hybrid is even better.

Other nice to have skills:

Usability factors for devices, scientific knowledge of what to measure, advanced degree in clinical, pharma, engineering, or science.

Required:

Experience developing sensor based instruments in clinical research,  health, sports, aviation or automotive industry—ideally wearable devices to sense biomarkers

Desired: can be different combinations/backgrounds

Clinical trials(can be pharma or medical device)

Knowledge of data analytics/visualization—anyone doing research or digital health or clinical research will have this

Scientific background—know what to measure—scientist in digital health

Operational experience—usability factors on devices

Medical device engineer for measuring biomarkers—mostly wearables like Fitbit

Digital health device development

Medical device development

Biomarker sensing device

Clinical trial tool

Biomarker tool

Digital health product design

Medical device engineer

Clinical tool engineer

Physiologist(this is Thomas’ background)

When he was asked what other titles he said Scientist in Digital Health

He also mentioned Engineer when he was talking about wearable medical devices.

Basically, it is a lot of either/or and different backgrounds that might fit.

Skills required:

  1. Experience in medical device engineering
  2. Clinical trials background
  3. Data Analytics
  4. Senior level position (10 plus years experience)

 

 

A premier biotech company in the San Francisco Bay Area is seeking a talented and experienced digital health technologist to work on several high-impact, high-visibility projects for the Early Clinical Development Informatics team.

Our team specializes in developing cutting-edge technology to optimize the clinical trial end to end. As a member of this team, you will be on the front lines, joining the team in scoping projects, implementing new functionality, and exploring and integrating technology into clinical development programs. If interested, you will also have the opportunity to grow your clinical development skills.

You will leverage your experience to engineer a seamless flow of clinical information. You will collaborate with a broad range of stakeholders involved in the clinical development process (e.g., Clinical Science, Clinical Operations, Medical Writing, Quality, Regulatory). Your work will also cross multiple therapeutic areas including oncology, immunology, neuroscience, metabolism, infectious disease, and others.

Together with cross-functional stakeholders, you will help develop industry-leading solutions for highly complex business problems. To manage the design and pilot of these technologies, you will apply a high degree of ingenuity and creativity while maintaining a finger on the pulses of the rapidly changing tech and healthcare landscape

Our team is highly entrepreneurial, with the freedom to pick our own projects, but with the support of a large company. We have a strong culture and very flat structure. Strong ownership of projects is encouraged.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

  • Key role is to bridge activities between ECDi, Clinical Science, and Clinical Operations and other key stakeholders with regards to development and deployment of digital health solutions.
  • Evaluates new, emerging sensor technologies for their potential use in Genentech ECD trials.
  • Supports the selection of external partners – academic or commercial – for the technology delivery as appropriate
  • Authors the relevant sections of a variety of clinical and regulatory documents including protocols, investigator brochures, informed consent, and clinical study reports
  • Supports the development and document authoring related to endpoint validation, biomarker qualification, and technology usage in clinical trials.
  • Collaborates with cross-functional members in the set-up, ingestion, and analysis of digital data to support the clinical database
  • Engages in the interpretation of clinical data and facilitates the interaction between statisticians, data scientists and clinical science. Understands the data needs for novel AI/ML algorithm creation based on structured data collection using digital technology

QUALIFICATIONS & EXPERIENCE:

  • Advanced clinical/science degree required (PharmD, PhD, MSN, MPH, etc.)
  • Knowledge of clinical research & successfully worked across Phase I – II drug development projects
  • Experience with sensor based measurements in clinical research, health, sports, aviation or the automotive industry
  • Broad experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance
  • Experience with developing digital clinical outcomes and digital endpoints
  • Well-versed in medical aspects of Google Cloud Platform (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • Experience with software development projects, and especially with functional requirement models like use case and user story development, and requirements gathering
  • Experience with user experience design
  • Knowledge of key requirements in IT security and data privacy design


Company Information

Since 1979, Advanced Software Talent has developed programs that are specifically designed to find and deliver world-class talent to technology-driven companies. With three decades of trendsetting work in our back pocket, we have earned a reputation for honesty, quality, and integrity.
Dice Id : atstaff
Position Id : 16611
Originally Posted : 3 months ago

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