EDC Configuration & Data Management Analyst

Compensation

: $83,690.00 - $125,470.00 /year *

Employment Type

: Full-Time

Industry

: Information Technology



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The EDC Configuration & Data Management Analyst will contribute to the support of breast and colorectal cancer research and the management of clinical trials by developing data management plans, applicable SOPs, supervising and performing database development testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and consistency of clinical trial databases. ESSENTIAL FUNCTIONS Develop and oversee development of all electronic database systems (EDC) and associated CRFs Perform clinical data management for trials in accordance with Good Clinical Data Management Practices Develop, implement and oversee relevant clinical data management documentation (i.e. Data Validation Plans, Data Management Plans, etc.) For electronic data capture (EDC) trials, oversee the complete project development process, from initial setup through database lock, including electronic case report form (eCRF) design and edit check design, development, and implementation. Perform user acceptance testing for clinical database. Liaison for NSABP physicians, pharmaceutical partners and the biostatistical vendor Training of staff in the use of software Organize and perform on-going data review to ensure timely and appropriate identification of errors, trends, discrepancies and quality issues Key liaison to establish, align, and confirm data management expectations Develop all relevant data management documentation Work closely with the research team to ensure accurate collection and recording of data both internal and external Implementation of study specific procedures to ensure compliance with regulations and internal best practices Serve as a participant on international Phase III operations committee providing support for specific international studies OTHER RESPONSIBILITIES Maintain professional knowledge by reviewing professional publications, attending professional meetings, and establishing personal networks. Able to travel to offsite meetings as required. Understand the policies, procedures, regulations, and practices necessary to conduct the normal function of this position. Maintain confidentiality and performs duties in a responsible and ethical manner. Perform additional duties as may be assigned. EXPERIENCE/SKILLS Bachelor's degree required: scientific area with emphasis on medical research preferred Must have excellent computer skills and pay close attention to detail Knowledge of CDASH and SDTM standards 3 5 years' research experience in a health care setting required Knowledge of FDA regulatory requirements, regulations pertaining to industry sponsored clinical trials and GCP Effective interpersonal skills that enhance communication with peers, physicians and outside vendors and partners
Associated topics: data administrator, data analyst, data center, data integrity, data warehousing, database, hbase, sql, sybase, teradata * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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