Clinical Data Manager I

1 - 5 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Excelya, one of the leading independent CRO in Europe, is a people-centered Contract Research Organization (CRO) committed to providing a personal and authentic experience within a young, ambitious health company. With a team of 900 Excelyates, we are on the path to becoming the clinical research leader in Europe. Our unique one-stop provider service model offers full-service, functional service provider, and consulting, allowing our Excelyates to evolve through a diverse array of projects. We collaborate with preeminent experts to advance scientific, managerial, and human knowledge for the improvement of the patient journey. As a Clinical Data Manager with Excelya, you will be responsible for performing Data Management tasks per client work orders to high regulatory standards and Clients SOPs. You will deeply acknowledge and strictly follow applicable Excelya and Clients SOPs, working under the supervision of more senior staff. Your responsibilities will include data cleaning, data review, discrepancy management, data reconciliation activities, generating study metrics and status reports, participating in study documentation archiving, and may be involved in EDC database build and testing through go-live. Additionally, you will complete administrative tasks as required and undertake other assigned tasks within the Excelya Group companies. Key Responsibilities: - Acknowledge and strictly follow applicable Excelya and Clients SOPs - Work under the supervision of more senior staff - Perform data cleaning, data review, discrepancy management, and data reconciliation activities - Collaborate with the Lead Data Manager for the study - Generate study metrics and status reports - Participate in study documentation archiving - May be involved in EDC database build and testing - Complete Excelya administrative tasks as required Qualifications Required: - Holds a Bachelor's degree qualification in a Scientific discipline - 1 or more years as a Data Manager or equivalent combination of education, training, and experience - Knowledge and understanding of ICH GCP and other relevant guidelines - Experience in clinical trial databases, data flow, and eCRF design - Proficient in computer technology - Effective verbal and written communication skills - Fluent in local language and English,

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