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    Clinical Data Manager

    Clario
    2+ years
    Preffered By Company
    Bangalore
    10 Oct. 15, 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 Posting for Clinical Data Manager at Clario

    Job Title: Clinical Data Manager
    Location: Bangalore, India
    Time Type: Full-time
    Posted On: Today
    Job Requisition ID: R15295

    About Us

    At Clario, we put people first, always. United and driven by patients, we are committed to making a difference, constantly seeking the best talent to help us transform lives. We value the contribution of each individual, as it is through our people that we can innovate technology that shapes the future of clinical trials.

    We are expanding our operations in India, offering remote working opportunities as well as career openings in our Bangalore, Pondicherry, and Mysore locations.

    Primary Responsibilities

    • Oversee Data Management Deliverables:

      • Ensure clinical trial databases meet project requirements.
      • Review documentation and requirements for new projects and anticipate impacts to Data Management (DM) standards/processes.
      • Collaborate with project teams to stay updated on changes affecting data collection, cleaning, and transfers.
      • Attend and participate in client meetings as requested.

    • Execute Data Management Plan:

      • Understand study implementation and data collection requirements.
      • Collaborate with the project team to develop study-specific edit check criteria.
      • Evaluate standard edit checks and recommend modifications as needed.
      • Maintain organized, complete, and up-to-date study documentation.
      • Develop and track timelines to ensure CDM project milestones are met.
      • Lead study setup, including TF design, database structure, specification, and approvals.
      • Coordinate and document the receipt and processing of electronic or ancillary data from outside sources.
      • Create and maintain the Data Management Plan when required.
      • Keep supervisor informed of project status.

    • Ensure Database Accuracy and Consistency:

      • Review data to identify errors/inconsistencies.
      • Collaborate with project teams to resolve data issues.
      • Track outstanding issues and follow-up until resolution.
      • Prepare and validate ad hoc data listings as necessary.
      • Report system bugs and enhancement needs to CDM Management and Engineering Product Manager.
      • Ensure accuracy in manipulation and scrutiny of clinical data, adhering to regulatory guidelines.

    • Mentorship and Team Support:

      • Train team members on departmental processes and documentation methods.
      • Assist team members with problem-solving and troubleshooting issues.
      • Lead by example with professional conduct.
      • Answer questions and propose technical solutions related to data management.
      • Delegate assignments to encourage growth and development.

    Secondary Responsibilities

    • Maintain Quality Service and Standards:

      • Adhere to all BioClinica CDM procedures, policies, and work instructions.
      • Understand and follow applicable Standard Operating Procedures (SOPs).
      • Assist in establishing and enforcing departmental standards.
      • Participate in the review and updating of company SOPs related to DM Services.

    • Contribute to Team Efforts:

      • Work with internal staff to resolve issues.
      • Explore new opportunities to add value.
      • Help others achieve results.
      • Perform other duties as assigned.
      • Participate in assigned departmental initiatives, including SOP development.

    • Maintain Technical and Industry Knowledge:

      • Attend applicable company-sponsored training.

    Equal Opportunity Statement

    Bioclinica is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

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