Clinical Data Developer

5 days ago

Bengaluru, Karnataka, India beBeeData Full time ₹ 9,00,000 - ₹ 12,00,000
Software Development Opportunity

The electronic Clinical Outcomes Assessment (eCOA) Build Programmer is a crucial role in the design, programming, and testing of clinical trial data collection databases.

This position requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization, and testing.

Collaboration with Data and Analytics colleagues is essential to deliver standardized data collection methods and innovative validation solutions for global clinical trials.

Responsibilities:
  • Gather and influence eCOA design specifications to ensure successful trial implementation.
  • Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components.
  • Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently, and in alignment with study objectives.
  • Partner with translation vendors to implement localized data collection.
  • Work with Clinical Build Programmer to ensure complete data build for trial data collection needs.
  • Provide insights into study level deliverables (ie Data Management Plan, Project Plan, database, and observed datasets).
  • Support submission, inspection, and regulatory response activities.
  • Lead cross Business Unit/Therapeutic Area projects or programs with high complexity.
  • Opportunity to develop and test new ideas and/or apply innovative solutions that add new value to the portfolio.
Requirements:
  • Bachelors degree in computer science, engineering, medical field, Informatics, Life Sciences, Statistics, Information Technology, or related analytics discipline.
  • At least 3 years of hands-on experience in database programming, or a combination of clinical data management, system validation, and data analysis.
  • Experience in the clinical, pharmaceutical, biotech, CRO, or regulatory agency sectors.
Preferred Qualifications:
  • Masters degree in computer science, engineering, medical field, Informatics, Life Sciences, Statistics, Information Technology, or related analytics discipline.
  • Quick learner to new trends in technology.
  • Excellent leadership, communication (written and oral), and interpersonal skills.
  • Demonstrated leadership in a professional setting.
  • Demonstrated teamwork and collaboration in a professional setting.
  • eCOA, eSource, or Direct Data Capture implementation.
  • Data analytics and visualizations.
  • Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions.
  • Deciding the technology platform (system/database) for data acquisition and aggregation.
  • Utilization of clinical/drug development knowledge and ability to liaise effectively with study team members.
  • Strong therapeutic/scientific knowledge in the field of research.
  • Project management experience.
  • Vendor management experience.
  • Familiarity with clinical data tools and technologies.
  • Understanding and experience in using data standards.
  • Knowledge of medical terminology.
  • Ability to balance multiple activities, prioritize, and manage ambiguity.

Role: Software Development - Other Industry Type: Pharmaceutical & Life Sciences Department: Engineering - Software & QA Employment Type: Full Time, Permanent Role Category: Software Development Education UG: Any Graduate PG: Any Postgraduate

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