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    Central Cra (Clinical Research Associate)- Registries

    Sanofi
    3+ years
    Not Disclosed
    Hyderabad
    10 Dec. 3, 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: Central Clinical Research Associate (Central CRA)
    Location: Hyderabad

    About the Job:
    The Central CRA at Sanofi Business Operations (SBO) plays a vital role in supporting rare disease registries globally. By leveraging your expertise, you will serve as the primary liaison for investigators and ensure the successful management of registries and clinical trials. You will be part of a dedicated team at SBO, which is built to centralize operations, reduce reliance on external vendors, and develop internal expertise across various Sanofi departments.

    Main Responsibilities

    Feasibility Activities

    • Collaborate with the Registries Team during site selection for registries.

    Study Start-Up Activities

    • Assist in collecting and reviewing site documents for Health Authority (HA)/Regulatory Authority (RA) submissions.
    • Prepare and manage submissions to Ethics Committees (EC)/Institutional Review Boards (IRB).
    • Customize and review Informed Consent Forms (ICF) to meet country-specific requirements.
    • Support site contract processes, including budget negotiations and agreements.
    • Ensure documentation compliance by uploading and filing study start-up materials in the eTMF system.

    Site Monitoring

    • Conduct remote and on-site monitoring visits (e.g., Site Selection, Initiation, Monitoring, and Close-Out) in line with protocols, GCP guidelines, and SOPs.
    • Review and manage electronic Case Report Forms (eCRFs) for data completeness and query resolution.

    Data and Safety Management

    • Monitor trial progress and quality, including safety reporting and adherence to local regulations.
    • Ensure audit/inspection readiness by conducting quality checks and implementing Corrective and Preventive Actions (CAPAs) when necessary.

    Stakeholder Management

    • Build and maintain collaborative relationships with site staff, investigators, vendors, and internal teams.
    • Resolve conflicts effectively and maintain regulatory compliance across all activities.

    Study Administration

    • Maintain study trackers, tables, and databases to monitor global progress.
    • Ensure timely and accurate reporting, including monitoring visit and progress reports.
    • Participate in investigator meetings, operational discussions, and quality audits.

    Performance Metrics

    • Monitor adherence to study timelines, visit frequency, and quality.
    • Assess data accuracy, regulatory compliance, patient recruitment, and retention.
    • Provide efficient reporting and communication to stakeholders.

    About You

    Experience

    • 3+ years of clinical research experience, including monitoring.
    • Rare disease, observational studies, or real-world evidence expertise is a plus.
    • Proven ability to work in global, matrixed environments.

    Technical Skills

    • Strong understanding of GCP guidelines, clinical trial processes, and regulatory requirements.
    • Proficient in data management, Microsoft Office, and medical terminology.

    Soft Skills

    • Excellent communication, interpersonal, and problem-solving abilities.
    • Strong ethical judgment and time management skills.
    • Adaptability and collaboration in dynamic environments.

    Education

    • Degree in a pharmaceutical, scientific, or related life sciences field.

    Languages

    • High proficiency in written and spoken English.

    Why Join Us?

    • Global Impact: Be part of a team driving innovation in healthcare.
    • Growth Opportunities: Access countless avenues for professional development, including global and cross-functional projects.
    • Inclusive Culture: Work in a diverse environment where every voice is valued.
    • Comprehensive Benefits: Enjoy high-quality healthcare, wellness programs, and 14 weeks of gender-neutral parental leave.

    Sanofi’s Commitment to Diversity and Inclusion:
    At Sanofi, we celebrate diversity and provide equal opportunities to all. Join us in pursuing progress and discovering the extraordinary.

    Learn more about our Diversity, Equity, and Inclusion initiatives at sanofi.com.

    Apply Now
    Become part of a team committed to improving lives worldwide. Let’s pursue progress together.

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