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    Clinical Research Lead

    Sanofi
    2+ years
    Not Disclosed
    Hyderabad
    10 Oct. 17, 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: Clinical Research Lead

    About the Job

    Our Team:

    Sanofi Business Operations is an internal resource organization based in India, dedicated to centralizing processes and activities that support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. We strive to be strategic partners for tactical deliveries to Medical, HEVA, and Commercial organizations globally.

    Main Responsibilities:

    As the Clinical Research Lead (CRL), you will oversee and manage clinical research activities, including the design, implementation, and monitoring of clinical trials to ensure they meet regulatory requirements and organizational goals. This role requires a robust background in clinical research, strong leadership skills, and a commitment to advancing medical knowledge and patient care.

    • Lead strategic activities including Clinical Development Plans (CDP), clinical sections of Integrated Development Plans (IDP), and contribute to defining the product value proposition and market access strategy in collaboration with various functions.
    • Provide medical input and support for clinical studies, including medical training, feasibility assessments, and medical reviews of data and documents.
    • Address inquiries from Health Authorities, IRBs/Ethics Committees, investigators, and study teams.
    • Oversee medical reviews of data, including safety events, and ensure accurate coding of events and drugs.
    • Contribute to centralized monitoring activities, including data validation, case reviews, and assessments of data quality.
    • Ensure effective recruitment and retention strategies are in place.
    • Lead the development and amendments of clinical protocols and informed consent documents.
    • Prepare and review clinical documents such as Investigator Brochures, Clinical Study Reports, and regulatory submissions.
    • Collaborate with stakeholders across functions to ensure compliance with Good Clinical Practice (GCP) and regulatory standards.

    About You

    Experience:

    • Strong scientific and clinical expertise with demonstrated experience in clinical development, preferably with Phase 3 trials.
    • Proven track record in protocol development, including designing clinical trial protocols and ensuring adherence to regulatory standards.
    • Experience in writing scientific publications and engaging with the scientific community is a plus.
    • Proficiency in interpreting clinical trial data and making data-driven decisions.

    Soft Skills:

    • Excellent communication and leadership skills, with the ability to collaborate effectively with external partners and diverse internal stakeholders.
    • Strong interpersonal and negotiation skills, with a performance-oriented mindset.
    • Problem-solving and decision-making abilities, along with effective teaching and training skills.
    • Open-mindedness to new digital solutions and ability to work within a matrix model.

    Technical Skills:

    • Deep understanding of scientific and clinical knowledge in relevant therapeutic areas (e.g., Pulmonary, Allergy, Immunology).
    • Ability to critically evaluate medical literature and maintain awareness of competitive products.

    Education:

    • Medical Doctor (MD)

    Languages:

    • Fluent in English (verbal and written)

    Pursue Progress, Discover Extraordinary

    At Sanofi, we believe in better—better medications, outcomes, and science. Progress happens through people from diverse backgrounds, united by a desire to make miracles happen. Join us in pursuing progress and discovering the extraordinary together.

    At Sanofi, we are committed to diversity and inclusion. We provide equal opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

    Watch our ALL IN video and explore our Diversity, Equity, and Inclusion initiatives at sanofi.com!

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