We're looking for a EDC Rave Study Builder, working in the Pharmaceuticals & Medical Products industry in Boston, Massachusetts, United States.
Supports the Associate Director, Integration & Innovation to implement a roadmap for emerging digital technology (e.g. artificial intelligence, electronic health record, etc.) to drive the company into the next-generation technology.
Facilitates in the development of a strategic roadmap for enhanced data mapping from source to reporting in both data visualization platforms and in delivery to the Quantitative Sciences (Biostatistics) business group.
Develops integration specifications and implements integration of both metadata and data point specific systems including, but not limited to, CTMS-like reporting metrics, vendor management oversight, sample tracking, eCONSENT, eCRF, AE/SAE safety indicators, etc. in order to provide a comprehensive user-friendly dashboard for predictive, risk-based monitoring of clinical trial information.
Creates platforms and processes for GCDM process, including data flow maps where technology is utilized in the efficient and effective collection of all data sources which result in data review, visualization, and regulatory reporting.
Serves as the subject matter expert on regulatory audits for data standards and technical CDM activities.
We're offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requires a Bachelors degree in a scientific discipline, information technology discipline or equivalent.
Experience in clinical data management for a minimum of 5 years
Expert with the electronic data capture (EDC) system Medidata/RAVE .
Experience with data integrations between clinical databases and industry-standard systems (e.g., CTMS, ePRO, IXRS, Argus).
Experience with data visualization tools (e.g., Spotfire, Looker, etc).
Experience in the design and validation of data collection instruments as well as data standardization, theory, design, collection, review, analysis, and display for implementation of standards across the company's organization.
Experience with oversight of: CDASH/CDISC (SDTM terminology), MedDRA and WHO-DD dictionary coding and versioning, SAS for data review, and software platforms across the biotechnology/pharmaceutical industry.
Thorough knowledge of medical terminology, clinical data management, and the clinical trial process.
Experience on regulatory requirements for data management and the regulatory submission process.
Experience in developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement.
Ability to review, interpret and evaluate clinical data.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.