Senior Clinical Data Manager (Sr CDM) - 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.

The Clinical Data Manager is responsible for performing Data Management tasks per client work orders to high regulatory standards and Client’s SOPs.

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

The role:

Excelya is looking to collaborate with a Full Service Provider Senior Clinical Data Manager (Sr. CDM) role, based in Bangalore, India.

The Senior Clinical Data Manager, is responsible for performing Data Management tasks per client work orders to high regulatory standards and Client SOPs.

Job General Responsibilities/Tasks:

Deeply acknowledges and strictly follows applicable Excelya and Client’s SOPs.
Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned to him/her.
Work closely with the Lead Data Manager responsible for the study.
Generate study metrics and status reports within and across several studies
Participate to study documentation archiving
Participate in EDC database build and testing through go live.
Senior CDM may act as a Lead Data Manager on simple studies
Senior CDM provides oversight for more junior staff
Complete Excelya administrative tasks as required e.g., timesheets, CV and 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

Holds a Bachelor’s degree qualification in a Scientific discipline is preferred
Five or more years as a Data Manager or equivalent combination of education, training and experience
Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance
Understanding of recommended CDM best practices and associated documentation.
Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)
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.
Effective verbal and written communication skills.
Fluent in local language and English (written and verbal)