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    Clinical Research Lead

    Sanofi
    5+ years
    Not Disclosed
    Hyderabad
    10 Dec. 10, 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

    Clinical Research Lead - Sanofi

    About the Job

    Our Team:
    Sanofi Business Operations is an internal resource organization based in India, designed to centralize processes and activities across multiple areas, including Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. We aim to be a strategic partner, ensuring effective tactical support to Medical, HEVA, and Commercial organizations globally.

    Main Responsibilities:
    The Clinical Research Lead (CRL) will manage and oversee clinical research activities, ensuring they meet regulatory and organizational goals. The role involves designing, implementing, and monitoring clinical trials, while ensuring compliance with regulatory standards. The ideal candidate will possess a strong clinical research background, leadership skills, and a passion for advancing medical knowledge and patient care.

    Key responsibilities include:

    • Leading strategic clinical activities such as the Clinical Development Plan (CDP), Integrated Development Plan (IDP), Target Product Profile (TPP), and market access strategies in collaboration with cross-functional teams.
    • Providing medical input for clinical studies, including feasibility assessments, medical review of data, and documentation support for the study team and stakeholders.
    • Handling medical queries from Health Authorities, Ethics Committees, Investigators, and other involved parties.
    • Managing the medical review of clinical trial data, including safety events and drug coding.
    • Overseeing Centralized Monitoring activities, including data validation, protocol deviations, and data quality assessments.
    • Supporting recruitment and retention strategies for clinical trials.
    • Leading the medical content development of protocols and informed consent documents in collaboration with the study team.
    • Preparing and reviewing clinical documents such as Investigator Brochures, Clinical Study Reports, Clinical Trial Authorization dossiers, and publications.
    • Collaborating with key stakeholders, including regulatory bodies, biostatisticians, clinical research teams, and CROs, to ensure smooth execution of clinical trials in compliance with GCP, applicable laws, and SOPs.
    • Managing clinical scientists within the team, as required.

    About You

    Experience & Skills:

    • Strong scientific, medical, and clinical expertise with a demonstrated track record in clinical development, including Phase 3 trials.
    • Extensive experience in protocol development, clinical trial design, and ensuring compliance with regulatory and ethical standards.
    • Proficient in interpreting clinical trial data, analyzing safety and efficacy data, and making data-driven decisions.
    • Knowledge of GCP guidelines and regulatory requirements governing clinical trials.
    • Proven leadership abilities and effective collaboration with internal and external stakeholders.
    • Excellent communication, negotiation, and presentation skills, with the ability to work in a matrix model.
    • Ability to apply innovative digital solutions to clinical research processes.

    Technical Expertise:

    • Deep knowledge in therapeutic areas such as Pulmonary, Allergy, or Immunology, or experience in drug development.
    • Expertise in reading and evaluating medical literature relevant to the molecule or therapeutic area.
    • Strong problem-solving and decision-making skills, with a risk-management approach.
    • Ability to ensure operational resources are available for continued clinical research activities.

    Education:

    • Medical Doctor (MD)
    • Fluent in English (verbal and written).

    About Sanofi:
    At Sanofi, we believe in equal opportunities for all and celebrate diversity. We are committed to fostering a culture where everyone is valued and supported. Our team works toward progress by embracing new ideas and striving for breakthroughs that will make a meaningful impact on patients' lives.

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

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