Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Data Management Science group contributes to Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation following international standards and GCP. The Data Quality Science sub-function is responsible for the identification, planning, and execution of key data quality-focused initiatives aimed at building Data Science's capability in delivering complete, correct, and consistently fit-for-purpose program/study data for the generation of enhanced analytical insights.
In the Senior Central Monitor role, you will be working with central statistical monitor lead and study team to identify and monitor potential risks related to clinical trials. They provide actionable recommendations related to clinical trial data risks and issues.
Role description:
Program- and Study-Specific Planning and Execution
- Develop and review of study metrics and triggers to identify potential critical risks to compliance, data quality, and patient safety.
- Define and review critical data requirements, processes, and Risk Assessment and Categorization Tool (RACT) by collaborating with cross-functional team members.
- Define and ensure consistency of key risk indicators (KRIs) with standards; collaborate with cross-functional team members to ensure KRIs are fit-for-purpose.
- Develop the study specific Risk-Based Monitoring (RBM) using an RBM system.
- Develop, test, and implement RBM system and/or tools, including user restrictions for data access, KRI, Central Statistical Monitor (CSM), and QTLs.
- Review KRIs, QTL outputs, and CSM review, as required, by using analytical reporting tool(s) to support the identification of risks and data patterns/trends.
- Track and investigate signals and quality indicators to determine best mitigation plan and follow-up.
- Perform root cause analysis, triage issues for follow-up and action, and communicate observations.
- Collaborate with Central Statistical Monitor in leading or supporting the data review discussion regarding the centralized monitoring observations.
- Create reports, metrics, and presentations to facilitate data reviews and decision-making.
- Collaborate with Global Study Operations to inform them of the details related to site risks/issues to plan site activities and monitoring visits.
Leadership in Risk-Based Monitoring
- Provide input to applications, databases, and systems used to monitor study data.
- Continuously evaluate and improve data management processes to enhance efficiency, compliance, and data quality.
- Develop, implement, and maintain quality control documentation.
- Implement global strategies, initiatives, processes, and standards.
Qualifications:
- PhD or MS degree (preferred) or BA/BS degree with a focus in statistics, computer science, life science, or related scientific discipline
- 3+ years of experience in clinical development, including technical experience within and outside of Data Management, programming, or RBM/RBQM activities, with PhD; 5+ years with MS, or 8+ years with BA/BS
- Technical ability to use risk-based tools/platforms and relevant technology effectively, e.g. clinical data visualization.
- In-depth working knowledge of SAS, R, Python, JavaScript, etc., is preferred.
- Proficient experience using commercial clinical data management systems and/or EDC products
- Working knowledge of clinical data and awareness of relevant data standards (e.g., CDISC, CDASH, SDTM).
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements, particularly related to risk-based monitoring.
- Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance in monitoring the clinical study.
- Strong interpersonal skills with demonstrated capability of working on multiple projects simultaneously.
- Ability to complete deliverables on time and adjust priorities in a fast-paced environment.
- Ability to work independently to drive RBM activities as a change champion, keeping the teams on track to risk management and oversight activities.
- Excellent leadership, communication, and coordination skills, with experience with project management and working with cross-functional teams. Strong critical thinking and analytical skills to understand/analyze complex data and provide insight into risk reports, trends, and data outliers.
- Proficient in Microsoft Word, Excel, and PowerPoint.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S., the salary range for this position is $ 153,800 to $ 230,600 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
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