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Senior Clinical Data Coordinator

3+ years
Not Disclosed
10 Dec. 4, 2024
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

Job Title: Senior Clinical Data Coordinator (CDC)

Location: Hyderabad, India
Company: Sanofi


About Sanofi

Sanofi is a global healthcare leader focused on innovation and transforming business processes to improve patient outcomes. As part of our Clinical Data Management team, the Senior Clinical Data Coordinator will play a vital role in supporting study data management activities, ensuring data quality, and helping shape the future of clinical trials.


Key Responsibilities

Data Management and Validation

  • Conduct data management activities including data validation, data review, and ensuring consistency and accuracy of clinical databases in line with study timelines.

  • Monitor and report the progress of data cleaning activities and provide updates to the Study Data Manager and study team.

  • Contribute to the creation of Data Management Plans and Centralized Monitoring Plans, ensuring compliance with study timelines and quality standards.

Testing and Database Revision

  • Participate in writing User Acceptance Testing (UAT) Plans and perform testing for databases, listings, patient profiles, and safety notification tools.

  • Collaborate with the programming team and Study Data Manager to resolve any issues found during initial database setup or revisions.

Centralized Monitoring & Communication

  • Perform centralized monitoring activities according to the established Centralized Monitoring Plan.

  • Communicate consistently and clearly about data management activities, ensuring any risks are identified, monitored, and escalated as necessary.

Mentorship and Process Improvement

  • Serve as a mentor for new Clinical Data Coordinators, providing guidance and fostering a collaborative team environment.

  • Identify opportunities to streamline data management processes, improving efficiency and data quality across projects.

Study Data Manager Support

  • Act as a backup for the Study Data Manager and support them in managing the study data lifecycle.


About You

Experience

  • Proven experience in Clinical Data Management, including knowledge of regulatory guidelines concerning data quality and clinical trial conduct.

Skills

Soft Skills:

  • High attention to detail with excellent accuracy in data management activities.

  • Strong communication skills, both written and oral, with the ability to collaborate effectively within teams.

  • Ability to foster positive working relationships within Clinical Data Management and with other study teams.

Technical Skills:

  • Strong knowledge of Clinical Data Management (CDM) tools and processes.

  • Proficiency in Microsoft Office Suite (intermediate level).

  • Familiarity with database technologies and a demonstrated ability to acquire and apply new technical skills.

Education

  • Bachelor’s degree or higher, preferably in a life sciences or drug development-related field.

Languages

  • Fluent in English (both verbal and written).


Why Join Us?

  • Innovative Environment: Be part of an international, innovative biopharma company at the forefront of Clinical Data Management Modernization.

  • Career Growth: Sanofi offers endless opportunities to grow your talent and drive your career forward, whether through promotions, lateral moves, or international opportunities.

  • Comprehensive Rewards: Enjoy a well-crafted rewards package that recognizes your contributions and amplifies your impact.

  • Inclusive Culture: Sanofi is committed to diversity, equity, and inclusion, providing equal opportunities to all employees.

Join us to be part of a team that is transforming the future of clinical trials and making a real difference in patients' lives.


Watch the 'One day at Sanofi' video and explore our Diversity, Equity, and Inclusion initiatives here.