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Senior Clinical Data Coordinator

5+ years
Not Disclosed
10 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Coordinator
Location: Hyderabad, India

About the Job
At Sanofi, we are driven by one mission: to chase the miracles of science and improve people’s lives. Our innovative global healthcare company is committed to providing an environment where you can flourish, grow your career, and make a real difference. Join us and be part of the team that is transforming healthcare.

As a Senior Clinical Data Coordinator within Clinical Data Management (CDM), you will work closely with the Study Data Manager, ensuring the completion of data management activities according to the agreed timelines. You will be responsible for ensuring the quality, accuracy, and consistency of clinical data in compliance with GCP and regulatory standards, and contributing to study data management activities, including data validation and monitoring.

Major Responsibilities

  • Ensure high data quality through data management activities such as data validation and review, adhering to study timelines.
  • Track and report data cleaning progress, generating status updates for the Study Data Manager and the study team.
  • Contribute to the creation of study plans, including Data Management and Centralized Monitoring Plans.
  • Participate in User Acceptance Testing (UAT) for databases and tools, providing feedback to programming teams and collaborating with the Study Data Manager to resolve any issues.
  • Execute centralized monitoring activities, ensuring timely communication regarding data management activities and risk identification, monitoring, alerts, and escalation.
  • Act as a mentor for new Clinical Data Coordinators (CDC), fostering collaboration within the CDM team and identifying opportunities to streamline processes.
  • Support the Study Data Manager and act as a backup when needed.
  • Provide insights into new approaches and initiatives within data management to improve team performance and data quality.

About You

  • Experience: Proven experience in Clinical Data Management with a focus on data quality and clinical trials conduct.
  • Soft skills: Attention to detail, excellent written and verbal communication skills, and strong team collaboration abilities.
  • Technical skills: Solid understanding of CDM processes and regulatory guidelines, experience with database technologies, and proficiency in Microsoft Office Suite (intermediate level).
  • Education: Bachelor’s degree or higher in a life science or drug development-related field.
  • Languages: Proficiency in English (both written and spoken).

Why Choose Us?

  • Career Growth: At Sanofi, we offer endless opportunities for career growth through promotions or lateral moves, whether at home or internationally.
  • Supportive Team: Work alongside a supportive, forward-thinking team in an innovative biopharma company.
  • Rewards: Enjoy a well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Innovation: Be part of the evolution of Clinical Data Management and the deployment of cutting-edge innovations in the field.

Sanofi is at the forefront of Clinical Data Management Modernization. Our ambitions are big, but achievable. Join us to help transform this vision into reality.