The core responsibility for this position is as a member of the Data Management department at Novotech. The Clinical Data Programmer-I (CDP-I) will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP).
ResponsibilitiesResponsibilities:The CDP-I shall be responsible for programming activities on a project. This shall include designing and implementation of clinical databases, programming of data review listings and programming of data reconciliation. The CDP-I shall ensure quality standards per SOPs and ICH-GCP.
Particate in project team meetings as required.
The CDP-I shall be responsible for programming activities on a project in different clinical trial applications in accordance with Novotech standards.
Perform database design and creation of entry screens per the design specifications for a project. This will also include alpha testing before releasing.
May assist in editing check programming per the edit check specifications for a project. This will also include alpha testing before releasing.
Perform data mapping/reconciliation programming per the data mapping/reconciliation specifications for a project. This will also include alpha testing before releasing.
Perform data listing programming per the data listing specifications for a project
This will also include alpha testing before releasing.
Performs status report setup and programming per the status report specifications for a project. This will also include alpha testing beforereleasing.
TheCDP-I may be requested to provide some programming related technical support on projects.
TheCDP-I may be requested to provide some trouble shooting and problem solvingrelated to programming on projects.
Perform external data setup in clinical trial applicationsper data transfer plan and clinical trial application specifications.
Perform external data loads, i.e. labs, ECGs etc., as needed.
Support the Project/ProgrammingLead on a project on tasks as needed.
Ensure all programming activitiesand processes performed are conducted in accordancewith standard operating procedures and good programmingpractices.
Support in the validation of electronic systems, software and programs implemented in accordance with current regulatory requirements.
QualificationsMinimum Qualifications & Experience:Graduate in information science or life science related field, or similar. Preferably at least six months to three years’ experience in a similar role in a CRO or pharmaceutical company.
Knowledge of clinical study protocol, hands on / learning experience in Medidata RAVE, Veeva and Viedoc and other market EDCs is preffered. Also, SQL, Phython, HTML, .NET, C# coding is required
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