The clinical data manager will work under the supervision of the Manager of Clinical Data Management. This individual will work closely with Biostatistics and Clinical Operations to run data management processes on clinical studies conducted by the Clinical Development department.
- Assist with the generation and maintenance of data management-related documentation including case report forms, data management plans and edit specifications
- Develop and perform user acceptance testing of clinical databases
- Perform clinical data entry as necessary.
- Perform ongoing data review and query generation, as required
- Assist with clinical database design activities.
- Provide specific reports or listings as required by internal personnel
- Apply and promote consistent data management standards
- Minimum of 1-2 years of data management experience in a pharmaceutical/medical device/CRO setting is desirable
- Bachelor's degree in a relevant scientific discipline including life and health sciences
- Excellent verbal and written communication skills
- Experience with relational databases and electronic data capture systems, preferably OpenClinica
- Knowledge of clinical study and data management processes from study design to data archival
- Ability to learn, create and maintain a working knowledge of regulatory guidelines, Good Clinical Practices and Standard Operating Procedures
- Ability to work in a team environment with data managers, clinical monitors, and biostatisticians.
- Knowledge of SAS and XML desirable.
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.
Myriad Genetics, Inc. (Nasdaq: MYGN) is a leading molecular diagnostic company making a difference in patient's lives through to discovery and commercialization of transformative molecular diagnostic products that assess a person's risk of developing disease, improve diagnosis, predict disease progression and guide therapy. We believe in improving the healthcare management of patients by providing physicians and patients with critical information across multiple medical specialties that addresses unmet medical needs. With fiscal year 2015 annual revenue of approximately $700 million and more than 2,000 employees, Myriad is focusing on strategic initiatives, including growing our existing markets, launching new products, and expanding our global presence to take advantage of significant long-term growth opportunities.