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    Senior Clinical Data Analyst

    Parexel
    3+ years
    Not Disclosed
    Bangalore
    10 Sept. 25, 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

    Join Parexel: Together, We Improve Global Health

    At Parexel, our shared mission is to enhance the world’s health. Through clinical trials, regulatory consulting, and market access solutions, we are driven by a deep conviction in the impact of our work. Each of us plays a crucial role in developing therapies that benefit patients, and we approach our responsibilities with empathy and commitment.

    Position: Senior Clinical Data Analyst

    As a Senior Clinical Data Analyst (7+ years of experience), you will independently lead and coordinate all clinical data validation activities on assigned projects with a high degree of proficiency. Your expertise will encompass providing technical guidance on Data Management (DM) operational activities, data cleaning matrices, and relevant documents, all in accordance with corporate quality standards and regulatory requirements. In this role, you will also serve as a subject matter expert on DM systems and processes, offering technical support and advice to both internal teams and external sponsors. You may act as a backup for the Data Management Lead as necessary.

    Key Responsibilities:

    • Data Validation:

      • Lead and oversee data validation activities during study conduct and database lock, including query management and data reconciliation.
      • Identify and communicate delivery risks and interdependencies, supporting mitigation strategies within the Risk Management Plan.

    • Data Management Documentation:

      • Set up and maintain DM documents in compliance with Standard Operating Procedures and ICH/GCP guidelines.

    • Study Start-Up and User Acceptance Testing (UAT):

      • Conduct user acceptance testing on clinical database setups.
      • Review protocols and EDC entry screens as needed.
      • Coordinate data management timelines and operational activities from database setup through project closeout.

    • Data Tracking and Entry:

      • Track and review CRFs, providing data entry support as required.

    • Quality Management & Compliance:

      • Ensure compliance with Standard Operating Procedures and ICH/GCP guidelines.
      • Lead quality control activities on databases and patient data as needed.

    • Training & Mentorship:

      • Ensure training compliance and provide on-the-job training to staff.
      • Mentor junior clinical data analysts and act as a subject matter expert on DM operational tasks.

    • Process Improvement:

      • Develop and implement project-specific tools to enhance operational efficiency.

    • Project Finance & Resource Support:

      • Analyze project variances and provide input for scope changes based on operational metrics.

    Skills:

    • Proven ability to lead and collaborate with global teams, coordinating tasks effectively.
    • Strong negotiation skills and the ability to influence stakeholders for mutual benefit.
    • Excellent problem-solving abilities, including root cause analysis and decision-making in complex situations.
    • Commitment to first-time quality with meticulous attention to detail.
    • Effective time management and prioritization skills to meet project deadlines.
    • Advanced communication skills, tailored to the audience with a diplomatic approach.
    • Ability to present information clearly and effectively.
    • Flexibility in adapting to new assignments and rapidly changing environments.
    • Strong accountability and innovative thinking to enhance data management processes.
    • Fluent in written and spoken English.

    Knowledge and Experience:

    • Advanced proficiency in Microsoft Office and data management systems (e.g., InForm, Rave, Veeva).
    • Strong understanding of data management processes, ICH-GCP guidelines, and regulatory requirements.
    • Familiarity with medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
    • Experience in clinical research, with knowledge of data validation workflows and database setup activities.
    • Basic knowledge of SAS programming and CDISC data standards.
    • Understanding of financial principles related to DM project management.
    • Experience leading global data management teams is desirable.

    Location: Office-based in Bengaluru or Hyderabad.

    Education: Bachelor's degree or relevant medical qualifications with applicable industry experience.

    Join us at Parexel and contribute to our mission of improving patient outcomes worldwide!

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