Job Title: Senior Clinical Data Manager (Sr CDM)
Location: Bangalore, India
Company: Excelya (Contract Research Organization)
Company Overview:
Excelya is one of the leading independent Contract Research Organizations (CRO) in Europe, founded in 2014. With a team of 900+ professionals, we provide innovative trial solutions across various therapeutic areas. We are committed to delivering life-changing therapies collaboratively while excelling with care in the clinical research field.
Role Overview:
Excelya is looking to collaborate with a Senior Clinical Data Manager (Sr CDM), based in Bangalore, India. The Sr CDM will be responsible for performing data management tasks per client work orders while ensuring adherence to high regulatory standards and Excelya’s SOPs.
Responsibilities:
Data Management:
Follow SOPs: Acknowledge and strictly follow Excelya and Client’s SOPs for all data management activities.
Data Cleaning & Review: Perform data cleaning, data review, discrepancy management, and data reconciliation activities on assigned studies.
Metrics & Reports: Generate study metrics and status reports for multiple studies.
Study Documentation: Participate in study documentation archiving and related activities.
EDC Database: Participate in EDC database build and testing through to go-live.
Oversight of Junior Staff: Provide oversight and support for more junior staff in data management tasks.
Lead Data Manager Role: Act as Lead Data Manager on simpler studies as needed.
Administrative Responsibilities:
Timesheets & Updates: Complete administrative tasks such as timesheets, CV updates, and training updates as required by Excelya.
Other Assigned Tasks: Undertake additional tasks related to any of the Excelya Group companies as assigned by the supervisor.
Requirements:
Qualifications & Experience:
Bachelor’s degree in a Scientific discipline (preferred).
Minimum of five years as a Data Manager or equivalent combination of education, training, and experience.
Strong knowledge of ICH GCP, and other relevant ICH, EU, or FDA guidelines to ensure regulatory compliance.
Experience in clinical trial databases, clinical data flow, data review, and eCase Report Form design.
Understanding of the clinical trial lifecycle (start-up, maintenance, and closeout).
Skills & Competencies:
Proficient in Microsoft Office tools (Word, Excel, PowerPoint, MS Project, etc.).
High level of professionalism, ethics, and compliance at all times.
Effective verbal and written communication skills in both local language and English.
Additional Information:
This is a full-time role based in Bangalore, India.
Fluent in local language and English (both written and verbal) is required for this position.
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