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    Senior Clinical Data Manager I

    Astrazeneca
    2+ years
    Not Disclosed
    Remote
    10 Oct. 22, 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: Senior Clinical Data Manager I
    Career Level: D1

    Join AstraZeneca: Shape the Future of Clinical Data Management

    As a Senior Clinical Data Manager I, you will play a critical role in coordinating Clinical Data Management (CDM) deliverables for assigned clinical studies. You may serve as an expert in CDM processes, standards, and technology, and could be a member of the Global Study Team (GST) for less complex studies. Collaborating with data management vendors and various departments, you’ll ensure that each study adheres to our specific operational models. You will also maintain business continuity for CDM processes, ensuring the integrity of the clinical database for relevant studies, often working under the guidance of an experienced Study Data Manager.

    Typical Accountabilities

    • Operational Support: Provide study-level CDM operational support based on the relevant model and DM Vendor, including documentation review, user access testing, query management, data cleaning, and third-party data reconciliation, in line with KPIs and project timelines.
    • Leadership & Knowledge: Demonstrate leadership and operational knowledge in planning and delivering CDM deliverables at a study level.
    • Day-to-Day Responsibilities:
      • Report study status to clinical study team members and provide data for medical and clinical reviews.
      • Collaborate with the Data Management Vendor/Study Data Manager on upcoming deliverables and milestone achievements.
      • Oversee data quality and documentation quality for deliverables and milestones.
    • Risk Management: Identify risks and collaborate with the Study Data Manager to develop mitigation strategies.
    • Therapeutic Knowledge: Understand therapeutic area data capture standards and AstraZeneca’s standards.
    • Regulatory Input: Provide input on CDM activities related to regulatory inspections/audits for assigned studies.
    • Software & Compliance: Contribute to the selection and usage of software systems and ensure compliance with Trial Master File requirements.
    • Continuous Improvement: Maintain awareness of external and internal models to promote continuous improvement in CDM operating models.
    • Mentorship: Mentor junior Clinical Data Management colleagues and handle ad-hoc CDM-related tasks from your Line Manager.

    Education, Qualifications, Skills, and Experience

    Essential:

    • University or college degree in life sciences, pharmacy, nursing, or a related field.
    • Comprehensive knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
    • Understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
    • Experience with clinical databases, data management systems, and electronic data capture (EDC).
    • Knowledge in leading studies, query management, and reconciliation activities.
    • Ability to manage multiple projects and deadlines effectively.
    • Excellent written and verbal communication skills.
    • Strong organizational and analytical skills with high attention to detail.

    Desirable:

    • Knowledge of the clinical and pharmaceutical drug development process.
    • Familiarity with database structures, programming languages, and data standards (CDISC).
    • Understanding of clinical data system design, development, validation, and interoperability.
    • Ability to work effectively with external partners.
    • Knowledge of SQL, 4GL, VBA, or R Programming.

    Key Relationships

    Internal (to AZ):

    • Clinical Data Management Teams
    • Statistical and Clinical Programmers
    • Statisticians
    • Clinical Colleagues
    • Clinical Quality Assurance and Compliance Teams
    • Core Team/Extended Study Team Members
    • Patient Safety Team
    • Biometrics Operations

    External (to AZ):

    • Third-party vendors supporting Data Management, including CROs
    • Vendors conducting Patient Safety

    Join Us

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team that represents a wide range of perspectives. We believe that inclusivity enhances our work. We welcome applications from all qualified candidates, regardless of characteristics, and comply with all applicable laws and regulations regarding non-discrimination in employment and recruitment.

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