Sr Technical Product Manager - Clinical Data Management

Natera San Carlos , CA 94070

Posted 2 months ago

POSITION SUMMARY

As part of our software engineering team, Clinical Database Product Managers (we are considering individuals at Senior Level for this opening) work with our internal business partners to provide value to the organization with software products including commercial and in-house LIMS (laboratory information management system) products. We support a variety of different business units such as laboratory operations, clinical operations, R&D, process development, customer support, genetic counseling, reporting, bioinformatics, statistics and more.

Clinical Database Product Managers need to be able to understand both the business processes of the groups we work with, and the technical details of the software to be an effective liaison for our department. This knowledge is used to discuss potential solutions and help drive decision-making.

FOCUS AREA

This position is focused on leading the clinical database product management effort to create a HIPAA-compliant clinico-genomic database. You will be gathering genomic & clinical data along with the longitudinal results data from various systems (internal & external) and building a centralized database that will be used to support internal teams for research purposes and possibly expanded as an external offering to pharma partners.

As a clinical database product manager, you will join a cross-functional team of oncology product management, data engineers, technical product managers and advisors to understand the business needs and come up with a plan to create a research grade centralized clinico-genomic database. You may lead a team of technical product managers working on supporting clinical operations (Clinical Trials , IITs etc.) across the organization.

PRIMARY RESPONSIBILITIES

  • Lead the effort in creating a de-identified clinico-genomic database that will be used for research purposes with the potential to be expanded as an external offering in the near future

  • Lead the effort in building and managing a data warehouse that acts as a centralized repository for the clinical and genomic data combined from different structured databases

  • Partner with Oncology product managers, Clinical and Clinical Trials TPMs to build and manage the roadmap genomics data warehouse

  • Work closely with the data management team to establish operational process & quality controls for research-grade curation of unstructured data into a queryable data model

  • Lead the use case development for commercialization of the clinco-genomic data service to external research partners

  • Support internal teams with research, publications and clinical trial design analysts and help analysts create dashboards that deliver insightful analytics to business stakeholders

  • Act as a subject matter expert on the clinico-genomic database and create a shared understanding among the users of this database

  • Produce deliverables that facilitate better understanding across all products such as data flow diagrams, data models, ERDs and other illustrations

  • Build confidence with our business partners by adding value to discussions, being responsive, and following through on action items

  • Participates in the preparation, presentation and review of clinical research documents that are generated using the clinico-genomic database

  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities

  • Maintain tracking of requests from user groups and prioritize those for time allotment and release planning

  • Aid in creation and communication of product roadmap and development schedules to the stakeholders

  • Incorporate a focus on quality into product design, and work closely with development and software quality assurance teams on product and process improvements

  • Keep up with industry trends and best practices, advising on new and improved data engineering strategies leading to improvement in data governance across the business, promoting informed decision-making, and ultimately improving overall business performance

  • Mentor junior team members

QUALIFICATIONS

  • BS or higher in related major or equivalent industry experience.

  • 6+ years of experience working on managing software systems related to clinical trials, device registries, clinical diagnostics, genomics or healthcare.

  • 4+ years of experience in clinical data management from CROs or pharma companies

  • Experience designing and building data pipelines to enable data-driven decisions for the business

  • Excellent problem solving and analytical skills to easily break down complex problems and deliver simple and effective data modeling solutions

  • Prior experience with Electronic Data Capture (EDC) systems , EMR integration and Clinical Trial Management systems is desirable

  • Knowledge of ICH/GCP guidelines, Clinical Research, Clinical Trial process and FDA regulations

  • Knowledge of industry data capture standards (CDISC, SDTM, CDASH) is a plus

  • Experience in implementing data privacy best practices/techniques is required

  • Good understanding of regulatory and GxP requirements including HIPAA, GDPR, HITRUST, CCPA, ISO-27001 etc.

  • Experience using interactive BI / data visualization platforms such as QlikView / QlikSense, Tableau, Power BI etc.

  • Structured and clear thinking with attention to detail

  • Effective verbal/written communication skills

KNOWLEDGE, SKILLS, AND ABILITIES

  • Knowledge in following areas of software development:

  • Software product requirements

  • Software technical design

  • Software project management

  • Software QA

  • JIRA or similar issue tracking system

  • Desirable technical skills:

  • DB design understanding and SQL skills

  • Comfortable with Linux command line usage

  • Object-oriented programming knowledge (especially Java)

  • Cloud/AWS basics

  • Experience with R or Python scripting is preferred

  • Very comfortable contributing to and leading meetings with business partners in a variety of positions and domain areas to receive product requests and guide decision-making

  • Ability to understand and describe technical complexities in a simplified way appropriate to different audiences

  • Ability to manage software systems related to genomics or clinical research that involves databases, dashboards, and ETL frameworks

  • Excellent written communication skills to produce clear, concise and correct technical documentation

  • Strong ability to comprehend complex problems and apply knowledge to propose potential solutions

  • Be able to break down large projects into granular milestones and track progress

  • Performs other duties as assigned

PHYSICAL DEMANDS & WORK ENVIRONMENT

  • Duties are typically performed in an office setting

  • This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material

  • Duties may require working outside normal working hours (evenings and weekends) at times

OUR OPPORTUNITY

Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits. Healthy catered lunches, Premium snacks and beverages, Onsite gym with cardio and weight-training equipment, Game room with satellite TV, Onsite dry cleaning and alteration service with pick-up and delivery, Employee-organized sport leagues, Happy hours and BBQs, Generous Employee Referral program.

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

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