Senior Clinical Data Manager
3 weeks ago
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya's vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.
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 projects.
To learn more about us, visit role:Excelya is looking to collaborate with a Full Service Pro vider 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 ResponsibilitiesDeeply 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 studiesParticipate to study documentation archivingParticipate in EDC database build and testing through go live.Senior CDM may act as a Lead Data Manager on simple studiesSenior CDM provides oversight for more junior staffComplete 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.
Requirements
Holds a Bachelor’s degree qualification in a Scientific discipline is preferredFive or more years as a Data Manager or equivalent combination of education, training and experienceKnowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory complianceUnderstanding 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)
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