This position is responsible for the tasks needed to ensure timely and accurate delivery of clinical study data.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Follow the processes set forth by the department SOPs and the study Data Management Plan to ensure the highest data quality within the organizations managed databases and for outsourced EDC databases.
- Develops and maintains data management plans, CRF completion guidelines and edit check specifications.
- Develops and tests edit checks.
- Develops and generates data cleaning programs in SAS
- Performs study data discrepancy review and generates needed queries.
- Monitors study progress as it relates to study data and generates related reports.
- Tracks outstanding data queries and facilitates timely query resolution.
- Participates in study team meetings to provide ongoing data status.
- Demonstrates knowledge of GCP/ICH regulations and 21 CFR Part 11.
- Additional duties as assigned.
- Bachelor’s degree or equivalent work experience.
- 2 years of experience working with clinical data.
- Basic SAS programming skills
- Experience with Data Management Systems desired.
- Excellent verbal and written communication skills.
Choice of health plans include medical, dental and vision coverage. Company-paid short-term and long-term disability and life insurance. Health and dependent care flexible spending accounts. Pre-tax travel expenses through TransitChek program. 401(k) plan. Generous paid time off (PTO). Ten paid holidays each year.
To be considered for this opportunity, please submit your resume, and refer to job title Clinical Data Manager” in your cover letter.
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org
CRF is an equal opportunity employer.