Sdtm Programmer

2 weeks ago

Bengaluru, India Excelya Full time

Created in 2014, Excelya is a contract research organization (CRO).
We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop provider service model - leveraging a full-service, functional service provider and consultancy - allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique

**Mission**
The SDTM Programmer is responsible for providing SDTM Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per client SOPs are delivered to high quality:

- Deeply acknowledges and strictly follows Sponsor SOPs, policies, and in-structions.
- SDTM Programmer 1 works under the supervision of more senior staff (manager or senior SDTM Programmer)
- Senior SDTM Programmer provides oversight for more Junior staff
- Work closely with the Lead Data Manager responsible for the study.
- Responsible to provide SDTM package (Annotated CRF, Reviewer guide, Define )
- Responsible for SDTM programming and to use Pinnacle 21 Community version for SDTM checks and define/SDRG preparation
- Archives Data Management programming documentation.
- Completes Excelya administrative tasks as required e.g., timesheets/time-cards, Follow Up documents, CV, and assigned trainings or training up-dates.
- May undertake other tasks as they may be assigned from the supervisor that will concern any of the Excelya Group companies.

**Requirements**:
The assignment requires the following skills:

- Bachelor’s degree qualification in a Scientific discipline is preferred.
- Experience:

- Level1: 1 year or more years as a SDTM Programmer or equivalent combination of education, training, and experience
- Level2: 3 years or more years as a SDTM Programmer or equivalent combination of education, training, and experience
- Senior level: 5 years or more years as a SDTM Programmer or equivalent combination of education, training, and experience
- Experience with SDTM programming
- Knowledge of Pinnacle 21. Should be able to use Pinnacle 21 Enterprise version for a given study
- Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance.
- Understanding of Clinical trial process and Data management activities
- Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc.).
- Ability to maintains high level of professionalism, ethics and compliance at all times.
- Demonstrated experience in managing multiple priorities in a highly dynamic environment
- Experience working in a matrix-structured environment is preferred
- Effective verbal and written communication skills.
- Fluent in local language and English (written and spoken).

**Résumé**:

- Type of job:
Full-time
- Location:
Bangalore, India
- Capability:
Data Management

**Contact**:

- **Bhavya M R**
Assistant Manager Human Resources

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