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    Senior Clinical Data Coordinator

    Sanofi
    2+ years
    Not Disclosed
    Hyderabad
    10 Nov. 7, 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
    Department: Clinical Data Management

    About the Role

    As a Senior Clinical Data Coordinator (CDC) at Sanofi, you will play a key role in ensuring the accuracy, consistency, and completeness of clinical data across various studies. You’ll work alongside the Study Data Manager to oversee data management activities and ensure that they comply with Good Clinical Practice (GCP) and relevant regulatory guidelines. This includes maintaining timelines, conducting data validation, and collaborating with the study team to address issues and optimize processes.

    At Sanofi, we are driven by a purpose: to chase the miracles of science to improve the lives of millions. As part of our Clinical Data Management team, you will help transform the way we conduct clinical trials and improve healthcare outcomes.

    Key Responsibilities

    • Data Management: Oversee and ensure data quality by conducting validation, review, and cleaning activities, following study timelines.
    • Progress Monitoring: Track the progress of data cleaning activities, generate status reports, and update the Study Data Manager and study team.
    • Study Documentation: Contribute to the creation of study documents, including the Data Management Plan and Centralized Monitoring Plan.
    • Database Testing: Participate in writing User Acceptance Testing (UAT) plans, and test databases, patient profiles, and safety tools, providing feedback to resolve issues.
    • Centralized Monitoring: Implement centralized monitoring activities as outlined in the Centralized Monitoring Plan and escalate any identified risks or issues.
    • Mentorship: Act as a mentor for junior Clinical Data Coordinators (CDCs), fostering an environment of collaboration, learning, and continuous improvement.
    • Process Improvement: Identify opportunities to streamline data management processes, increase data quality, and contribute to new initiatives within the team.
    • Back-Up Support: Provide support and back-up to the Study Data Manager as needed.

    About You

    • Experience: Proven experience in Clinical Data Management, ideally within the biopharma or clinical research industry.
    • Skills:
      • Strong attention to detail and high level of accuracy.
      • Excellent communication skills, both written and verbal.
      • Ability to work well in a team and foster positive collaboration within Clinical Data Management and with clinical study teams.
      • Technical proficiency in Clinical Data Management (CDM), including knowledge of relevant regulatory guidelines and database technologies.
      • Proficiency in Microsoft Office Suite (Intermediate level).
    • Education: Bachelor’s degree or higher, preferably in a life science or drug development related field.
    • Languages: Proficient in English (both verbal and written).

    Why Choose Sanofi?

    • Career Growth: Access a wide range of opportunities for professional development and career progression, both locally and internationally.
    • Innovative Work: Join a company at the forefront of Clinical Data Management modernization and help us implement innovative solutions that shape the future of clinical trials.
    • Rewards and Recognition: Sanofi offers a competitive rewards package designed to recognize your contributions and drive.
    • Diversity and Inclusion: We are committed to creating a diverse, equitable, and inclusive environment where all employees can thrive.
    • Global Impact: Be part of a global team dedicated to improving the lives of millions through groundbreaking science.

    Sanofi's Commitment to Diversity and Inclusion

    Sanofi is an equal opportunity employer and provides equal opportunities to all individuals regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity. We celebrate the diversity of our team and are committed to creating an inclusive environment for all.

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