Director, Clinical Data Management
- Remote, Home Office, United States
- Employees can work remotely
- Department: Clinical Operations
Aurinia exists to make a difference. From the earliest days of the company, we’ve seen the potential in applying a creative, thoughtful and responsible approach to developing and commercializing therapies with a goal of changing the course for patients in disease areas that have been historically challenging to address. We Care, for our patients and our employees.
We are currently commercializing a treatment of lupus nephritis (LN) in the United States and preparing for potential commercialization of this compound in the EU, UK, Russia and Japan with Otsuka Pharmaceutical. We are also looking to leverage our internal capabilities to advance additional innovative therapies which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.
This role is responsible for overseeing clinical data management from start-up through close out of clinical trials to ensure data quality and integrity. The individual will independently lead data management for all programs to ensure complete, accurate, high quality, and regulatory compliant data in support of study reports, publications, and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance patient care.
- Develop and build CDM function within the company including standard operating procedures (SOPs) and processes with a focus on continuous improvement and increased efficiency.
- Responsible for relationships with and oversight of CDM partners from protocol development to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope.
- Oversight of study-related data management activities for outsourced projects including but not limited to, CRF design, data collection, edit checks & offline listings review, external data reconciliation, Serious Adverse Event reconciliation, medical coding, quality control of database, database locks and archival of data management documents.
- Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the company goals.
- Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF).
- Other such duties as may be determined or assigned.
- Master’s degree required within a scientific discipline, Nephrology experience a plus.
- 10+ years of clinical data management experience in Sponsor or CRO setting.
- Comprehensive understanding of data management systems and technologies, Electronic Data Capture systems and CDISC data standards.
- In-depth knowledge of drug development, study conduct processes, GCPs and regulations related to clinical data management as well as ICH/FDA/EU guidelines.
- Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
- Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to create solutions and enable decisions.
- Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team.
- Highly organized and detail-oriented with a passion to deliver quality results.
- Strong verbal and written communication skills with an ability to build relationships internally and externally.
- Highest levels of professionalism, confidence, personal values and ethical standards.
All candidate information will be kept confidential according to EEO guidelines