Analyst II External Data Acquisition Expert Amgen Technology Private Limited

5.0 - 10.0 years

5 - 10 Lacs

Mumbai, Maharashtra, India

On-site

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We're looking for an experienced professional to join our team in Hyderabad, accountable for the setup and maintenance of External Data Streams within assigned clinical trials. You'll ensure these streams adhere to best practices and defined guidelines, contributing to the integrity and efficiency of our clinical data. 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 .

Posted 5 days ago

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