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Technical Data Manager Ii – India

3+ 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

πŸ“Œ Technical Data Manager II – India | Excelya

πŸ’Ό Company: Excelya
πŸ“ Location: India
πŸ•’ Type: Full-time, Permanent Contract

About Excelya

Excelya is an independent Contract Research Organization (CRO), created in 2014, focused on delivering high-quality, people-centered services. With a team of 900 Excelyates, we aim to be the clinical research leader in Europe, providing a wide range of services including functional service provider and consulting models. We work collaboratively with experts to enhance the patient journey, and our team members benefit from an environment that fosters personal and intellectual growth.

Position Summary

Excelya is seeking a Technical Data Manager II based in India. This role involves handling Technical Data Management tasks in compliance with Excelya and client SOPs. The position requires expertise in eCRF design, EDC database management, and data validation. The Technical Data Manager will work closely with the Lead Data Manager to ensure data quality, regulatory compliance, and efficient project execution.

Key Responsibilities

βœ” Data Management: Design eCRFs, manage EDC databases, write data validation plans, and implement edit checks.
βœ” Collaboration: Work closely with the Lead Data Manager to ensure efficient management and execution of the study.
βœ” Global Libraries: Responsible for maintaining global libraries in the EDC database.
βœ” Documentation: Assist with study documentation archiving.
βœ” Administrative Tasks: Complete required timesheets, CV updates, and training records.
βœ” Ad hoc Responsibilities: Perform other tasks as assigned by the supervisor.

Skills and Attributes

πŸ’‘ Regulatory Knowledge: Knowledge of ICH GCP, EU, and FDA guidelines.
πŸ’‘ Technical Expertise: Proficient in eCRF design, EDC database management, and clinical data flow.
πŸ’‘ Communication: Strong verbal and written communication skills in both English and the local language.
πŸ’‘ Ethics and Professionalism: Ability to maintain high professionalism and ethical standards at all times.

Qualifications and Experience

πŸŽ“ Education: Bachelor’s degree in a scientific discipline (preferred).
πŸ’Ό Experience:

  • Minimum 3 years as a Technical Data Manager or equivalent experience.
  • Experience with clinical trial databases, data review, and eCase Report Form design.
  • Understanding of the clinical trial lifecycle from start-up to closeout.

Additional Requirements

  • Ability to travel as necessary (up to 25%).

Excelya’s Culture

At Excelya, we foster a stimulating professional environment where Excelyates can express their talents and grow in a collaborative, values-driven culture. We offer a unique experience that supports both professional development and operational success.

πŸ“© Apply Now