Job Description
The Data Manager will be responsible for data management activities in small or medium sized projects under direct supervision, or in a supportive data management role in large, complex studies.
Communication
- Secondary or back-up communication point for project teams and company departments with regard to clinical data management
- Secondary or back-up communication point for clients for clinical data management aspects of clinical projects and data management reporting
Data Manager
- Tracking database set-up, testing, maintenance and data entry
- Shared responsibility for clinical data management activities within clinical projects
- Input into design of CRFs and other data collection forms; review case report form design for accuracy and adherence to protocol
- Development of CRF completion guidelines
- Coding medical data with coding dictionaries and cording listings review (DMs with medical/biology background, additional training required)
- SAE reconciliation
Document Management
- Liaise with Document Center with regard to maintenance of PMF and ePMF (CRFs/queries/study documents)
Quality Control
- Database QC checks
- Shared responsibility for attending internal and client/third-party audits/inspections of Data Management
Training
- Training of Assistant Data Managers
- Project-specific training of investigators and clinical team in CRF completion
Corporate/Departmental Assignments
- Investigator Meetings preparation/attendance
- Meetings and teleconferences organized by client preparation/attendance
Qualifications
Education:
College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
Experience:
- At least 2-years' experience in a professional environment, preferably with clinical or medical data
- Experience in Clinical Database systems (Clintrial, Medidata Rave, Oracle InForm) is desirable
- Proficiency in MS Office applications
- Organisational and time management skills
- Ability to work independently and multi-task
Additional Information
Advance your career in clinical research and develop new skillsets whilst growing with the organization.