Description
ESSENTIAL FUNCTIONS:Perform data management activities on both paper based and Electronic data capture (EDC) studies. Major activities include:
- Responsible for the design and development of Case Report Forms (CRF) in collaboration with CRAs or Clinical Project/Program Managers.
- CRF data review, preparation for entry, query processing, discrepancy management, ad-hoc reporting, listing generation.
- Develop edit check requirements with the help of Clinical Research Associates (CRA) and field monitors.
- Work closely with clinical database programmers to provide specifications at the time of study database development and work on Post production changes.
- Create and maintain data management plans, Data Review guidelines and other study specific work instructions or guidelines for multiple projects.
- Perform Remote Data Capture study user acceptance testing and database QC.
- Mentor CDMs and other staff as necessary
- Act as a point of contact with vendors such as Database developers, coders, Safety personnel, QA etc.
- Assist in overall project tasks such as generating CRF completion guidelines, process flowcharts, Standard operating procedures (SOP), work instructions, training guidelines etc.
- Assist with database design and validation activities.
- Participate in project meetings to give a status update to project managers and upper management.
MINIMUM REQUIREMENTS:
Education and Experience:
Bachelor's Degree required. Education in Sciences preferred.
5 years relevant experience of which at least 4 years are in a medical device and/or pharmaceutical data management environment.
Preferred Skills/Qualifications:
- Computer proficiency in MS Word, Excel, PowerPoint, Access, ORACLE Clinical, CRF design tools etc.
- Excellent Data management skills on various types of clinical trials (Pharma and/or especially Device)
- Experience with OC Remote Data Capture (RDC) or other EDC systems.
- Clindex preferred
- Experience with reporting tools (e.g. TOAD, Discoverer, Crystal Reports, etc.) preferred.
- Excellent organizational skills and attention to detail.
Competencies:
- Action Oriented
- Composure
- Conflict Management
- Customer Focus
- Ethics and Values
- Functional/Technical Skills
- Interpersonal Savvy
- Managerial Courage
- Managing and Measuring Work
- Process Management
- Approachability
- Priority Setting
- Problem Solving
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
Will work primarily within Clinical Affairs but may have to interact with the Quality and Regulatory Affairs staff. May interact with outside vendors. Scope will include multiple clinical studies at a time.
To find out more about Real please visit www.realstaffing.com