|Reference # :||20-07940||Title :||Clinical Data Associate|
|Location :||San Rafael, CA|
|Experience Level :||Start Date / End Date :||08/31/2020 / 08/31/2021|
Client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. Client aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative Client therapeutics, advancing the standard of care and providing personalized support and services globally.
Client Biometrics is responsible for designing, capturing, analyzing and presenting data that can drive key decisions for Clinical Development, Medical Affairs and other business areas of Client. With a quality-by-design culture, Biometrics builds quality data that is fit for purpose to support statistically sound investigation of critical scientific questions. The Biometrics team develops solid analytics that are visually relevant and impactful in supporting key data driven decisions across BioMarin.
The Data Management Operations team is responsible for the efficient and effective delivery of complete, correct, and consistently fit-for-purpose data sets for statistical analysis across all clinical development and post-approval programs. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program-related data management activities such as: protocol review, Case Report Form (eCRF) development, Data Management Plan development, Data Validation Plan development, requirement specifications, reconciliations, and data quality validation activities
The Data Associate / Sr. Data Associate supports Data Management Program and/or Data Management Study Lead in the execution of assigned data management tasks for all study related data management activities including protocol review, eCRF development, Data Management Plan development, Data Validation plan development, reconciliations and the delivery of complete, correct, and consistently fit-for-purpose study data sets for statistical analysis.
Participate in all or part of the following activities as delegated by the Data Management Program or Study Lead
The Data Associate / Sr. Data Associate will be in individual contributor and will not require any people management. The position will contribute to, and make an impact, on project or study team outputs.
Master's or bachelor's degree with a focus in Health Sciences
2-5 years of experience inclinical development experience inclusive of technical experience within and outside of Clinical Data Management
Equipment required will primarily be a computer
This position will interact with a range of personnel across the Development Science Operations organization including but not limited to other Biometrics and Clinical Operations personnel
There is now supervisor responsibility
This position requires the following skills:
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.