Data Manager - DF/Net Research
DF/Net Research, Inc. is a contract research organization providing data management, statistical support, programming, and medical coding to pharmaceutical, biotechnology, academic and non-profit institutions worldwide. In collaboration with our Canadian office, DF/Net Software, the company uses, sells, supports and develops the DataFax data management system. DF/Net manages the data for several of the world’s top research organizations making a difference in global public health today. Our areas of work include HIV, leishmaniasis, hookworm, TB, malaria, Ebola, oncology, vision, and other areas of health care.
Applies knowledge of health care and project management skills to data management responsibilities from study development through study closure, including CRF creation, study database setup, testing, and documentation; internal and external study team training; data collection, tracking, and cleaning; study closeout activities; and overall project management. Participate in company software and infrastructure development. Provide training and mentoring to junior level data management staff.
Essential Duties and Responsibilities:
- Perform as a liaison and primary contact for the study sponsor and collaborators.
- Translate protocol requirements into data collection instruments.
- Maintain and monitor Data Management study timelines.
- Coordinate with Data Analytics team.
- Coordinate study team; train and mentor junior staff.
- Develop and provide written and oral presentations as needed.
- Develop Case Report Forms (eCRFs/CRFs).
- Define and tests databases.
- Develop edit checks.
- Develop study specific Data Management Plans, maintain study documents.
- Perform and document study closeout activities.
- Manage data quality control activities.
- Validate data, review data queries, and generate QC reports.
- Perform additional study and projects, as needed.
- Maintain a consistent work schedule in accordance with departmental and company expectations.
- Comply with industry regulatory requirements and standards and DF/Net Research Standard Operating Procedures (SOPs).
- Bachelor’s degree in Public health or related field.
- Experience with clinical trial research and/or database management.
- Knowledge of clinical trial activities and Good Clinical Data Management Practices.
- Master’s degree or equivalent experience.
- At least one year of experience with DataFax and/or clinical trial data and/or research studies.
- Experience with Electronic Data Capture (EDC).
- Experience with international clinical trials.
- Knowledge of FrameMaker.
- Familiarity with CDISC standards.
Knowledge, Skills and Abilities
- Demonstrated ability to multi-task and appropriately prioritize work assignments.
- Ability to work independently.
- Ability to work collaboratively in a team environment.
- Flexibility to work in changing research environment.
- Exceptional attention to detail.
- Proficient computer skills.
- Management skills.
- Ability to establish and maintain productive work relationships.
- Strong verbal and written communication skill.
- Sitting for prolonged periods of time.
- Repetitious computer usage.
- Regular office environment.
- Occasional travel, including international, based on projects assigned.