QuidelOrtho
is hiring
Senior Data Analyst, Clinical
About Our Company
We embrace intelligence to illuminate the path forward
Technology for humanity
We provide access to answers across the entire diagnostics continuum. With our help, patients, clinicians and communities can spot trends sooner, respond quicker and chart the course ahead with greater accuracy and confidence.
Passion for the unknown
We know diagnostics has the power to unlock a healthier future for all. For over 80 years, we’ve relentlessly pursued the unknown with a passion and purpose to improve health. And, with our industry-leading expertise in immunoassay and molecular testing and award-winning solutions in clinical chemistry and transfusion diagnostics, we'll continue to raise the bar, bringing clarity and insight in settings from home to hospital, lab to clinic.
Transforming diagnostics
Our innovations have changed diagnostics. From our dry chemistry that delivers testing access where there is none, to respiratory testing and tracking breakthroughs that offer much needed intelligence in a world of uncertainty, we’re at the forefront of diagnostic science and care.
Possibility to probability
Turning complex data into actionable health insights is more than a mission. We understand patients, their families, clinicians and care providers worldwide depend on our products for answers that save lives—and we innovate every day to exceed their expectations.
Job Description & Responsibilities
As we continue to grow as QuidelOrtho, we are seeking a Sr. Clinical Data Analyst who will be responsible for planning, developing, and maintaining clinical study databases to support regulatory submissions of in vitro diagnostic products. The Sr. Clinical Data Analyst will support continuity of data, dataflow and data accessibility for clinical databases. This position is hands on, actively leveraging expertise to deliver best practices in clinical data management that includes, but not limited to, data cleaning, monitoring, querying regularly and when requested.
This is a remote position.
The Responsibilities
- Reviews data validation procedure outputs and initiates query generation. Interacts with clinical sites to resolve data discrepancies.
- Develops data management and data validation plans, data entry instructions as well as other required documents and performs database lock/freeze procedures.
- Designs Clinical Data Management Systems (CDMS) databases with input from clinical scientists, biostatisticians, and scientific programmers.
- Programs data entry screens and validation procedures.
- Responsible for the completeion and doucmentation of User Acceptance Testing.
- Retrieves Instrument data from appropiate sources and applies data validation procedures.
- Provides data management expertise as a member of Biostatistics & Data Science team.
- Participates in the selection, training and supervision of contract research organizations (CRO) contracted for data entry and data management activities.
- Develops department procedures related to data handling and database validation.
- Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other clinical study documents as required.
- Manages the workflow and ensures accuracy of CRO database deliverables.
- Create and communicate data monitoring reports on a regular basis and when required.
- Maintains data integrity in a clinical data base systems.
- Helps improve the scope of our data sets by identifying new data collection and procurement opportunities on an ongoing basis.
- Carries out duties in compliance with established business policies.
- Performs other duties as assigned.
Requirements
Required Skills
- Bachelor's degree required in a computer science/technical/scientific field.
- Minimum 3 years of clinical data management experience.
- 3 years of experience with clinical data management systems such as Medidata RAVE, Medrio, Oracle Clinical, or ClinTrial.
- 3 years of experience in programming data entry screens and validation procedures in a clinical data management system.
- Proficiency in the area of clinical data collection and cleaning.
- Knowledge of FDA/GCP/ICH/ISO guidelines related to clinical study database and data management.
- Must be able to work both independently and within a cross-functional team environment.
- Proven oral and written communication skills.
- Experience in using R or SAS software required.
- Experience in manipulating / managing complex large and unstructured databases data set.
- Solid understanding of database principles, such as relational and non-relational databases, data architecture.
- Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Preferred
- Experience in SQL and other query languages is preferred.
What we offer
The salary range for this position is $78,600.00 - $145,000.00.
QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
