Danaher Corporation Staff Clinical Data Analyst (Real World Data)Remote in Miami, Florida
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The Staff Clinical Data Analyst for Beckman Coulter Diagnostics is responsible for technical and daily application support of clinical studies for new and improved projects in Sepsis and COVID-19 following GCP and FDA requirements.
This position is part of the Clinical Affairs organization and can be remote or based in one of Beckman Coulter’s offices in Brea, CA; Miami, FL; or Chaska, MN.
You’ll be an integral part of Data Management and report to the Senior Staff Data Manager. This role is responsible for supporting data management project needs and activities to ensure that applicable policies, procedures, and regulatory standards are followed.
In this role, you will have the opportunity to:
Support development of the real-world clinical data management documentation for clinical studies, such as data management plan, CRF design, data dictionaries, data validations, data specifications and acceptance criteria, and data transfer agreements.
Execute real-world clinical data management activities throughout study lifecycle, such as supporting site initiation activities, reconciling electronic data transfers, validating data quality. Also responsible for preparing data for statistical review and/or data management audit, performing database lock and freeze activities, coordinating the archiving of study databases and related documents, and performing close out audits.
Serve as liaison with clinical site IT groups, Algorithm Development and Clinical Affairs teams to ensure robust data transfer and data quality processes are implemented and followed: supporting sites with defining data dictionary elements, data de-identification, data acceptance criteria, and data transfers.
Develop database clinical trial data specifications and ensure compliance throughout study lifecycle. This includes eCRF design, user requirements, edit rules/checks, query logic, and data validations.
Assist in database upgrades/migrations including performing user acceptance testing.
Partner with IT and implementation team(s) to address clinical application requests and/or changes to clinical database systems.
Collaborate with study team members within data management and clinicals groups to implement study activities, improve processes, and generate novel solutions where required.
The essential requirements of the job include:
Bachelor's degree with 9+ years relevant experience or Master's degree with 7+ years relevant experience or Doctoral degree with 4+ years of experience – degree in: Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences or related field.
Experience with real-world electronic health record data to generate real-world evidence in supporting regulatory submissions. This includes cleaning, harmonizing, qualifying, analyzing data.
Knowledge of real-world clinical data management activities, such as developing and executing clinical data management documentation, developing study dataset specifications, working with CDISC, etc.
Strong communication, data presentation and visualization, and writing skills.
Experience within a diagnostic, medical device or pharmaceutical organization.
It would be a plus if you also possess previous experience in:
Knowledge of sepsis therapeutic area.
Experience using a high-level programming language such as R, Python, SQL for complex data analysis and reproducible research practices.
Understanding of validation requirements for software tools.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.