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Clinical Programmer Ii

2 weeks ago

Chennai, India Allucent Full time

The CP II works on studies with mínimal supervision from Senior CP and/or Clinical Programming Management.

The CP II is a member of the Data Management staff.

**Requirements**:

- Design, build, test and release clinical databases to the production environment
- Develop and maintain all clinical programming documentations, including study design specifications, User’s Acceptance Test (UAT) plans, test cases and database configuration settings in support of database set-up and edit checks programming.
- Develop and/or review Data Validation Plan
- Program electronic edit checks and data listings required for data review and validation process
- Review electronic Case Report Form (eCRF) Completion guidelines
- Develop and/ or validate SAS programs for metric reporting, data review listings, data import and data export set-up
- Review and adhere to the requirements of study specific data management documents & plans
- Lead and coordinates clinical programming activities for assigned studies (including monitoring of project timelines, scope of work, budgets, resourcing needs and escalating potential problems effectively and in a timely manner)
- Actively contributes/participates in study team, departmental meetings, sponsor meetings and uses analytical approach to problem solving
- Collaborates with peers, programmers, study teams to clarify specifications and uses expanded technical skills to meet evolving project needs
- Understand validation principles and requirements and consistently develops code in accordance with those requirements
- Help to align clinical programming best practices, standards, global libraries and conventions within the company
- Assist in standardizing data management procedures such as documentation for departmental operating procedure
- Maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading literatures, self-training, attending training classes, professional meetings etc.
- Research and propose initiatives for improving efficiency
- Actively support to staff learning & development
- Develops and delivers applicable DM departmental trainings
- Train and mentor data management and clinical programming staff
- Proactively track data management development trends and updates, in consultation with department Director, for further alignment and improvement of current processes
- Draft and contribute as Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System
- Contribute to other areas of business as required
- _
- 3 years of relevant work experience
- 3 years of experience in drug development and/or clinical research
- knowledge of ICH-GCP(R2),
,
and applicable (local) regulatory requirements