Clinical Data Manager

3 giorni fa

Milano, Italia PSI CRO A tempo pieno

**Company Description**
We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2700 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.
- Remote of Office Based_

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
- Full working proficiency in English
- 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.

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