Analyst II External Data Acquisition Expert

5 - 10 years

5 - 10 Lacs

Posted:1 month ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

setup and maintenance of External Data Streams

Key Responsibilities

  • Accountable for the setup and maintenance of

    External Data Streams

    within assigned trial(s) according to best practices and defined guidelines.
  • External Data Streams include, but are not limited to,

    ePRO, eSource, EHR, Real World data

    , and traditional and novel clinical data streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS).
  • Your activities and deliverables will include, but are not limited to:
  • Development of

    trial-specific data transfer agreements and specifications

    .
  • Verification of data transfers

    .
  • Setup of automated data ingestion

    into the clinical data repository.

Principal Relationships

  • Reports to

    : A people manager position within the functional area (e.g., Data Acquisition Leader).
  • Functional Contacts within IDAR (Internal)

    : Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
  • Functional Contacts within JJ Innovative Medicine (as collaborator or peer)

    : Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources, and Project Coordinators.
  • External Contacts

    : External partners and suppliers, CRO management and vendor liaisons, industry peers, and working groups.

Education and Experience Requirements

Required

  • Bachelor's degree (e.g., BS, BA)

    or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees (e.g., Master, PhD) are preferred.
  • Approximately

    5+ years of experience

    in the Pharmaceutical, CRO, or Biotech industry or a related field.
  • Proven knowledge of data management practices

    (including tools and processes).
  • Proven knowledge of regulatory guidelines

    (e.g., ICH-GCP) and standards (e.g., CDASH, SDTM).
  • Intermediate project and risk management skills

    with an established track record of delivering successful outcomes.
  • Established track record collaborating with

    multi-functional teams in a matrix environment

    and partnering with/managing stakeholders, customers, and vendors.
  • Strong communication, leadership, influencing, and decision-making skills.
  • Strong written and verbal communication skills (in English).
  • Demonstrated

    technical expertise developing and maintaining External Data Streams

    (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS) and associated components (e.g., Data Transfer Agreements, Specifications, transfer file verification, data ingestion set-up).

Preferred

  • Innovative thinking for optimal design and execution of clinical development strategies.
  • Ability to contribute to the development and implementation of business change or innovative ways of working.
  • Experience working with data from

    EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms

    .

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