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    Clinical Data Manager Ii (India)

    Innovaderm Research
    10+ years
    Not Disclosed
    India
    12 Nov. 24, 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 Data Manager II

    Overview
    As a Clinical Data Manager II at Innovaderm, you will play a key role in ensuring that clinical trial data is captured, managed, and reported with accuracy, clarity, and security. This end-to-end role encompasses everything from protocol review to database lock, offering you the opportunity to lead multiple studies, work closely with clients, and make critical recommendations.

    Responsibilities

    Data Management Lead

    • Monitor study status, including enrollment and case report forms (CRFs) monitored/approved.
    • Present deliverables to clients, gather feedback, and propose solutions.
    • Provide regular data status reports to project teams.
    • Oversee Clinical Data Coordinators and vendor performance to ensure quality and timeliness.
    • Maintain clinical databases, conducting data review/cleaning and preparing for database lock/close.
    • Reconcile external data with EDC system data, including adverse event/serious adverse event (AE/SAE) reconciliation with sponsor safety databases.

    Study Setup – Technical

    • Develop the data management plan (DMP).
    • Build study-specific clinical databases using EDC systems, including designing electronic case report forms (eCRFs).
    • Coordinate database validation and user acceptance testing (UAT).
    • Support external clinical data systems (ePRO, IWRS) and manage data transfer requirements.

    User Training and Support

    • Develop eCRF completion guidelines and training materials.
    • Train site users and monitors on the clinical database.
    • Manage user access to the clinical database and maintain records of access requests.
    • Respond to user queries regarding the EDC system.

    Database Close/Lock

    • Generate data listings and reports for data review.
    • Ensure all data management documentation is updated and archived in the trial master file (TMF).
    • Archive clinical databases and related documents.

    Requirements

    Education

    • Bachelor’s or Master’s degree in a related field.

    Experience

    • 10 years of clinical data management experience in the pharmaceutical or CRO industry.
    • 5 years as a lead data manager.
    • Extensive experience with EDC systems (preferably Medrio and Medidata Rave).

    Knowledge and Skills

    • Strong organizational and project planning skills.
    • Proficiency in English (written and verbal communication).
    • In-depth understanding of clinical trial regulations, including GCP and ICH guidelines.
    • Familiarity with CDISC SDTM/CDASH standards.
    • Knowledge of MedDRA and WHODrug dictionaries is an asset.

    Why Innovaderm?

    Perks and Benefits

    • Flexible schedule and vacation benefits.
    • Home-based position with opportunities for ongoing learning and development.
    • Collaboration with a team of brilliant and driven colleagues in a supportive environment.

    About Innovaderm

    Founded in 2000, Innovaderm is a Contract Research Organization (CRO) specializing in dermatology. Based in Montreal, the company is renowned for its high-quality research and exceptional client service, with operations expanding across North America and Europe.

    Commitment to Equity
    Innovaderm ensures equitable treatment and equal opportunities for all, offering accommodations for applicants with disabilities during the recruitment process upon request.

    Applicants must be legally authorized to work in India.

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