Senior, Clinical Data Management

Location: Miami, FL, United States
Date Posted: 07-27-2015
Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world, Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies.
Biorasi hires talent and personality, not position holders. We’re a non-traditional work environment requiring only top performers. Every team member is a stock-holding owner and our culture reflects it.
Unlimited potential for professional, financial and personal growth. If you are after broad and growing responsibilities coupled with full authority, are keen on doing the job your way, without bureaucracy getting in the way of key decisions, and truly believe that a well-structured operational infrastructure is one of the key components to a company’s success, then this unique opportunity is for you.
This is a remarkable opportunity to dedicate yourself to leading a vital function of a growing company and benefiting professionally and financially from your accomplishments. If you have an entrepreneurial mind-set, a passion for achievement and are looking for a place to explore your potential, Biorasi wants to talk to you now.
The Role
The Associate of Data Management & Analytics responsibilities are outlined below:
Primary Responsibilities:
  • Design and development of clinical study databases in electronic data capture (EDC) systems, eCRFs adhering to CDASH and general CDISC standards as well as study protocol requirements.
  • Perform eCRF tracking and data review procedures for clinical study trial data collected for multiple studies performed for various phases to identify data discrepancies and ensure there is internal consistency within the data.
  • Perform management of EDC queries, including query issuance and resolution.
  • Develop database validation specifications (DVS), eCRF Completion Guidelines, and Data Management Plans (DMP).
  • Manage external data handling, reconciling external vendor data against clinical study database.
  • Maintain user access to study systems, ensuring compliance with 21 CFR Part 11.
  • Participate in internal team meetings and sponsor meetings.
  • Perform assigned tasks for multiple studies within project timelines.
Secondary Responsibilities:
  • Perform User Acceptance Testing for development study databases; create User Acceptance Testing scripts for study database validation.
  • Create data management reports as requested.
  • Assist with the preparation, collection, and archival of study related clinical documents.
  • Clinical team training on EDC system, study-specific eCRFs, and RTSM applications.
  • Participate in vendor management as assigned.
Candidate Profile
  • Bachelor degree or equivalent in a scientific related discipline.
  • Minimum 6yrs of experience in Clinical data Management. 
  • Experience with Access, SQL, Crystal Reports, JReview, Business Objects XI, or any other reporting tools/coding languages a plus.
  • Advanced Excel knowledge preferred.
  • Excellent organizational skills; strong verbal and written communications skills.
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants 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. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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