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    Clinical Data Operations Lead

    Novartis
    7+ years
    Not Disclosed
    Hyderabad
    10 July 31, 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, 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 Data Operations Lead

    About the Role:

    The Clinical Data Operations Lead is an integral part of the data42 Clinical Data Pipeline team at Novartis, responsible for overseeing all data operations related to clinical data assets. This role involves centralizing clinical data collected across Novartis clinical studies to enable secondary research, including the handling of raw and analyzable clinical data from various databases (EDC, lab, and third-party data). Reporting to the Clinical Data Pipeline Owner, the Lead will collaborate with other data42 teams to ensure data ingestion, mapping, and harmonization according to CDISC SDTM/ADaM standards. The data will be curated, medically recoded (WHODrug/MedDRA), and anonymized following Good Clinical Data Management Principles, ensuring timely and high-quality deliverables.

    Key Responsibilities:

    • Lead clinical data operations for data42, ensuring overall data delivery aligns with use case needs and Clinical Data Pipeline releases.
    • Functionally manage local associates, providing guidance to Subject Matter Expert (SME) squads on functional expertise and processes.
    • Make data transformation and standardization decisions and translate use case needs into data operations.
    • Ensure alignment with Good Clinical Data Management Principles in clinical data pooling activities.
    • Communicate effectively with stakeholders, ensuring quality and timely delivery of clinical data operations and reporting.
    • Build and maintain relationships with cross-functional teams, summarizing and discussing deliverable statuses and critical aspects like timelines, scope, and resource planning.
    • Comply with company, departmental, and industry standards (e.g., CDISC, NCI) and processes (GCDMP, ICH-GCP).
    • Maintain and update knowledge of Clinical Pipeline software and methodologies, attending relevant functional meetings and trainings.
    • Contribute to process improvement initiatives, focusing on anonymization and reporting procedures.
    • Oversee recruiting and coordination of internal and external data managers, acting as a functional manager locally for associates.

    Key Performance Indicators:

    • Achievement of goals with high-quality and timely deliverables as assessed by the Clinical Data Pipeline Owner and customers.
    • Effective representation of the clinical data operations function, with good communication and team behaviors.
    • Collaboration with other data42 product teams.
    • Effectiveness in training, mentoring, and coordinating internal and external analysts.

    Impact on the Organization:

    • Successful and efficient delivery of high-quality Clinical Golden tables.
    • Innovative solutions and improvements supporting efficient Clinical Golden data deliverables.
    • High-quality work supporting the data42 Clinical Data Pipeline team.
    • Efficient team organization and a conducive working environment.

    Minimum Requirements:

    • Education: BA/BS/MS in statistics, computer science, mathematics, life sciences, or a related field.
    • Experience: Ideally 7+ years in clinical data management or related roles within the pharmaceutical or healthcare industry, including experience in leading data management activities and teams.
    • Skills:
      • Strong understanding of data management methods and strategies.
      • Knowledge of industry standards, including CDISC data structures and WHODrug/MedDRA dictionaries.
      • Understanding of regulatory requirements relevant to Clinical Data Management (e.g., GCP, study procedures).
      • Familiarity with the Agile KANBAN framework.
      • Proven communication, negotiation, and project management skills, with experience in complex global matrix structures.
      • Some people management skills are required.
      • Ideally, basic knowledge of AI/ML.

    Languages:

    • Fluent in English (Oral and Written)

    Why Novartis:

    Join a community of smart, passionate individuals at Novartis, working together to achieve breakthroughs that change patients' lives. Learn more and consider joining the Novartis Network for future career opportunities.

    Location: Hyderabad, India

    Division: Biomedical Research
    Business Unit: Pharma Research
    Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
    Functional Area: Research & Development
    Job Type: Full-time, Regular
    Shift Work: No

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