Clinical Data Specialist
6 days ago
Excelya is one of the leading Contract Research Organizations (CROs) in Europe, founded in 2014 and headquartered in Paris. Our global team consists of over 900 experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.
Our approach to work is based on collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development. This collaborative environment enables us to deliver high-quality services to our clients.
We aim 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 become the clinical research leader in Europe.
For our team members, excelling with care means benefiting from a stimulating professional environment that encourages personal, intellectual, and operational participation. This allows us to 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 www.excelya.com.
The Role:We are looking for a Senior Clinical Data Manager to collaborate with our team in Bangalore, India.
This role involves performing Data Management tasks per client work orders to high regulatory standards and Client SOPs.
Job Responsibilities:- 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.
- Works closely with the Lead Data Manager responsible for the study.
- Generates study metrics and status reports within and across several studies.
- Participates in study documentation archiving.
- Participates in Electronic Data Capture (EDC) database build and testing through go live.
- May act as a Lead Data Manager on simple studies.
- Provides oversight for more junior staff.
- Completes Excelya administrative tasks as required, e.g., timesheets, CV, and training updates.
- May undertake other tasks as assigned by the supervisor that concern any of the Excelya Group companies.
Requirements
- Holds a Bachelor's degree qualification in a scientific discipline (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.).
- Able to maintain a 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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