The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. And the problem is only getting worse.
TrialSpark is a new healthcare company that owns the end-to-end drug development process. Our proprietary technology allows us to integrate and improve clinical research for patients, providers, and sponsors, while executing clinical trials faster and cheaper.
As a Senior Clinical Data Manager at TrialSpark, you will take a hands-on approach to building out our practices in this area. You will coordinate with all Operations team members (clinical project managers, medical leads, quality assurance personnel, monitors, statisticians, study sponsors, etc.), ensuring that projects remain on track and clinical databases have been designed to provide the highest quality of data. Key data deliverables include responsibility for database programming, data analytics, and a central monitoring function to support risk based and remote monitoring strategies. This position reports to the Head of Clinical Data Management.
Skills and Competencies
- Knowledge of Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and regulatory requirements related to clinical data management processes, documentation and software
- Knowledge of and ability to apply CDASH/CDISC standards
- Ability to adapt to rapidly changing situations and multiple requests
- Ability and drive to learn new software and systems both with direction and independently
- Experience writing and maintaining data management plans, CRF completion guidelines, detailed work instructions and SOPs
- Hands-on experience with OpenClinica, Medrio, Viedoc or other cloud-based, SaaS EDC systems
- Excellent communication, organization, time management and inter-personal skills
- Self-starter, able to communicate well within a team environment
Education and experience
- Bachelor's degree in related field of study
- 5+ years as a data manager and/or clinical database programmer or equivalent combination of education and experience in a CRO or related environment
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.