Location
Bangalore | India
Job description
The Clinical Programmer II (CP II) leads and coordinates clinical programming activities and maintains clinical databases and other application tools supporting data capture and data processing in compliance with study specific plans, standard operating procedures, industry standards and regulatory requirements.
The CP II works on studies with minimal supervision from Senior CP and/or Clinical Programming Management.
The CP II is a member of the Data Management staff.
- 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
- Support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH, TAUGs and SDTM models
- 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.
- 4 years of relevant work experience
- 4 years of experience in drug development and/or clinical research
- knowledge of ICH-GCP(R2), , and applicable (local) regulatory requirements
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Leadership and mentoring opportunities
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms.
Job tags
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