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Senior Clinical Data Manager (Sr. Cdm) – India

5+ years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

📌 Senior Clinical Data Manager (Sr. CDM) – India | Excelya

💼 Company: Excelya
📍 Location: Bangalore, India
🕒 Type: Full-time, Permanent Contract

About Excelya

Excelya is a leading independent Contract Research Organization (CRO), founded in 2014, that focuses on a people-centered approach to clinical research. With a dynamic team of 900 Excelyates, we aim to become the clinical research leader in Europe. We deliver exceptional services through collaboration with experts and offer a professional environment where our team members can grow and thrive.

Position Summary

We are looking for a Senior Clinical Data Manager (Sr. CDM) based in Bangalore, India. This role involves overseeing the data management tasks of clinical studies, ensuring compliance with high regulatory standards and client-specific SOPs. The Senior CDM will perform tasks like data cleaning, review, and reconciliation while collaborating with the Lead Data Manager and providing mentorship to junior staff.

Key Responsibilities

Data Management: Responsible for data cleaning, review, discrepancy management, and reconciliation activities for assigned studies.
Collaboration: Work closely with the Lead Data Manager to manage study-related activities and participate in EDC database build and testing.
Study Documentation: Assist with study documentation archiving.
Leadership: Provide oversight and mentorship to junior data management staff and act as Lead Data Manager on simpler studies.
Administrative Tasks: Complete administrative tasks such as timesheets, CV and training updates.
Ad hoc Responsibilities: Undertake additional tasks assigned by the supervisor related to any Excelya Group companies.

Skills and Attributes

💡 Regulatory Knowledge: Knowledge of ICH GCP, EU, and FDA guidelines.
💡 Data Management Tools: Proficient in clinical trial databases, eCRF design, and data review processes.
💡 Leadership & Mentorship: Ability to lead and provide oversight to junior staff.
💡 Communication: Strong verbal and written communication skills in both English and the local language.

Qualifications and Experience

🎓 Education: Bachelor’s degree in a scientific discipline (preferred).
💼 Experience:

  • Minimum 5 years as a Data Manager or equivalent experience.
  • Experience with clinical trial databases and data management best practices.
  • Knowledge of the clinical trial lifecycle from start-up to closeout.

Excelya’s Culture

At Excelya, we create an environment where our team members can grow professionally while contributing to the improvement of the patient journey. Our collaborative, values-driven culture encourages intellectual and operational participation, allowing each Excelyate to express their unique talents and evolve.

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