FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in Health, Education, Nutrition, Environment, Economic Development, Civil Society, Gender, Youth, Research and Technology– creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories. We are currently seeking qualified candidates for the position of Lead Data Management Associate in Shanghai, China.
Position Description:
Responsible for the capacity development of clinical research sites in a Chinese Research Network (CRN). Development of a capacity development plan and implementation and development of training. Oversight of day to day operations of case report form (CRF) processing, data entry and filing, and data querying activities for a clinical trial. Oversees and provides support to Data Entry clerks for a clinical trial. Responsible for providing support to data collection sites. Manages all standard operating procedures (SOPs) and work instructions (WIs) for data management activities.
Key Responsibilities
- Responsible for the capacity development of clinical research sites in a Chinese Research Network
- Development of a capacity development plan for sites within Chinese network
- Implementation of plan
- Development of training for sites as needed within CRN.
- Responsible for data management tasks related to a clinical trial.
- CRF processing of forms upon arrival at the data management center.
- Monitors Data entry and filing of CRFs at the sites where entry is performed.
- Assists with data entry and cleaning for sites that cannot perform entry.
- Data cleaning of CRF data in study database.
- Manage the assignment of duties and schedules within the data management group.
- Coordinates project scheduling.
- Supervises the administrative activity (hiring, reviews, etc.) of the data management group.
- Support of sites completing CRFs.
- Provide feedback to sites of CRF completion problems.
- Monitors data cleaning and trouble shoots problems
- Finalize and maintain all SOPs and WIs for the data management group.
- Draft SOPs and WIs are written by the Query Manager, Programmer, and Data Entry Clerks. The Data Manager finalizes these documents, manages their version control, and supervises their training and implementation.
Expertise and Complexity
Excellent administrative skills and organizational ability.
- Through knowledge of basic assumptions of clinical trial practices for data acquisition and quality assurance.
- Through knowledge of clinical data management tools such as Excel, Word, and Access.
- Verbal and written communication skills.
- Bilingual Mandarin Chinese/English preferred.
May supervise one or more staff members.
Up to 25% travel may be necessary.
Minimum Requirements:
Education/Experience:
High School graduate and 7 - 9 years relevant experience; Or, Diploma and 5 - 7 years relevant experience; Or, BSc/BA with related course work and 3 - 5 years related work experience; Or MS/MA with related course work and 1-3 years related work experience.
Experience as Data Manager in Clinical Trials in China.
Bilingual Mandarin Chinese/English preferred.
FHI 360 has a competitive compensation package. Interested candidates may register online through FHI 360's Career Center at www.fhi360.org/careercenter or through the Employment section atwww.fhi360.org. Please submit CV/resume and cover letter including salary requirements. Please specify source in your application.
