Clinical Data Manager
Location: Salt Lake City, UT, United States
Job Identification: 1122
Job Schedule: Full time
- Monitor and manage clinical study data collection for retrospective and prospective studies
- Generate and/or review study documents (e.g. Data Management Plans, Data Dictionaries, Data Review Documentation, DM/Trial Master File documents, study protocols, etc.)
- Generate, maintain, and/or review standard operating procedures or work instructions
- Process data and prepare for internal or external delivery
- Write and/or review standard operating procedures
- Assist with management of data management and clinical operations database systems
- Assist with sample management activities, including receipt and tracking of clinical samples and coordinating sample management with research and development personnel
- Monitor case report form receipt and data entry process, if applicable
- Develop and execute database queries and perform discrepancy management
- Timely review and resolution of discrepancies through communication with internal and/or external study staff
- Ensure procedures are followed for database locks prior to study analysis and reporting
- Bachelor's degree, scientific discipline preferred
- Must have a minimum of 2 years experience in clinical data management
- Excellent writing skills
- Experience with clinical data management database systems
- Collaborative interpersonal skills with ability work both independently and as part of a team
- Ability to multi-task and adapt to rapidly changing demands of fast paced and novel start-up environment
- Knowledge and understanding of GCP/GCDMP
- Attention to detail a must
- A sense of humility and an eagerness to contribute to a supportive, interdisciplinary team
- Experience in medical diagnostic clinical trials
- Experience with FDA, ICH and CLIA guidelines and regulations
Physical and Mental Job Requirements
- Repetitive Motion, analyzing
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is frequently required to sit; talk; or hear.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch
- The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, distance vision and depth perception.
About UsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com .
WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender,national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
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