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    Signal Manager (Centralized Monitoring)

    Sanofi
    2+ years
    Not Disclosed
    Hyderabad
    10 Nov. 15, 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

    Job Title: Signal Manager

    Location: Hyderabad, India
    Grade: L1-2

    About the Job:

    Join Sanofi’s Risk-Based Monitoring (RBM) team as a Signal Manager and play a key role in managing signal-related activities for clinical trials. Risk-based monitoring is an adaptive approach that targets critical data and processes, enhancing patient safety and data quality. In this role, you will be responsible for analyzing clinical and operational data, ensuring the reliability of trial results, and optimizing the monitoring strategy to align with regulatory requirements and Sanofi’s mission to drive quality, efficiency, and speed in clinical trials.

    The Signal Manager will manage RBM activities from study kickoff to database lock, providing insights and collaborating with the local team to implement adaptive monitoring strategies. This is a dynamic, data-driven role offering significant growth potential within a global healthcare leader.

    Main Responsibilities:

    • Study Risk-Based Monitoring Strategy Execution: Implement and operationalize the study's RBM strategy, focusing on Quality Tolerance Limits (QTLs) and methodologies in line with Sanofi’s standards and study timelines.
    • Monitoring Coordination: Develop site monitoring schedules based on site risk and workload, and collaborate with central monitors to manage on-site and remote monitoring activities.
    • Generate Risk Signals: Oversee Key Risk Indicators (KRIs), Data Quality Assessments (DQAs), and QTLs to identify and analyze risk signals at the site, country, and study levels. Propose corrective actions to the Central Monitor (CM).
    • Risk Escalation and Tracking: Promptly escalate identified risks to relevant stakeholders, including Central and Site Monitors, and track resolution of these issues.
    • Risk-Based Strategy Support: Assist the Central Monitor in defining a tailored risk-based strategy for each assigned study, ensuring alignment with Sanofi’s objectives and regulatory requirements.

    About You:

    • Experience: Experience in trial operations, data management, or quality management, with familiarity in clinical research regulatory requirements (including ICH GCP guidelines).
    • Skills: Proficient in data analysis and providing actionable insights. Strong project management, communication, and presentation skills.
    • Technical Skills: Experience with MS Office (Excel, Word, PowerPoint, SharePoint) and ability to use business intelligence dashboards.
    • Education: Bachelor’s degree or higher, preferably in life sciences or related fields.
    • Languages: Strong English communication skills (both verbal and written), with the ability to work in a global environment.

    Why Choose Us?

    • Career Growth: Explore endless opportunities for career development, from promotions to lateral moves, in an international and supportive environment.
    • Comprehensive Rewards: Receive a thoughtful rewards package that recognizes your contributions, including health benefits, wellness programs, and at least 14 weeks of gender-neutral parental leave.
    • Work Environment: Collaborate with a team driving innovation in clinical monitoring, while enhancing the reliability of clinical data.

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