FierceBiotech and FiercePharma Jobs
Medical Coding Specialist - Randstad US
Jun 15
Location: Cambridge, MACategories: All Categories
Website: http://www.randstadjobs.com
Position Description
Position Summary: Codes all applicable clinical trial data with standardized terminology and participates in the development of database standards and data management procedures that relate to clinical data coding
Duties and Responsibilities:
• Compares and reconciles adverse event data captured in Product Safety with adverse event data captured on case report forms
• Codes adverse events, concomitant medications and other data as needed using standardized terminology (e.g., MedDRA, WHODRL)
• Develops coding conventions for MedDRA for coding data other than adverse events (e.g., Medical History, Physical Exam data, etc.)
• Participates in the development and enforcement of Coding Policies in conjunction with Product Safety, Regulatory Affairs, Clinical Research, Medical Writing and Biostatistics
• Designs and produces data listings for review of the accuracy, completeness and consistency of clinical trial coded data in conjunction with Clinical, Product Safety and Biostatistics
• Works in conjunction with the Data Manager to specify database edit checks and follow data discrepancy resolution procedures for coded data
• Monitors timelines to ensure deadlines are met for data calls and database lock activities
• Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Process Guides related to coding activities
Supplemental Activities:
• Assists the Director, Data Management with projects as assigned
Qualifications:
Experience: BS/RN/RPH degree in health-related field (RN or RPH preferred) with 4+ years of clinical data management experience in the pharmaceutical/biotechnology industry or an MS degree; knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in the oncology, inflammation and cardiovascular field desired
Other:
• Detail orientation
• Excellent written, verbal and organizational skills
• Expertise using WHOART, WHODRL, MedDRA
