SDTM Programmer (I,II & Senior) - India

Excelya, one of the leading independent CRO in Europe.

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

To learn more about us, visit www.excelya.com.

The role:

Excelya is looking to collaborate with a Full Service Provider SDTM Programmer, based in Bangalore, India.

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.

Job General Responsibilities/Tasks:

Deeply acknowledges and strictly follows Sponsor SOPs, policies, and instructions.
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/timecards, Follow Up documents, CV, and assigned trainings or training updates.
May undertake other tasks as they may be assigned from the supervisor that will concern any of the Excelya Group companies.

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Requirements:

Bachelor’s degree qualification in a Scientific discipline is preferred.
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)