Clinical Business Integration Specialist

4 weeks ago

Bangalore, India Winning Edge Full time
Job Title: Clinical Business Integrator

Job Summary:

We are seeking a highly skilled Clinical Business Integrator to join our team at Winning Edge. As a key member of our clinical research team, you will be responsible for partnering with clinical business stakeholders to discuss opportunities to optimize and transform using tech solutions.

Key Responsibilities:

  • Partner with clinical business stakeholders to discuss opportunities to optimize and transform using tech solutions.
  • Act as domain lead and represent the clinical tech team in discussions with clinical business teams.
  • Be an advocate of the data science vision of the tech team to introduce breakthrough innovations and cater to efficiency gains.
  • Work with Engineering team to design, develop, and maintain IT systems and applications used in clinical research and drug development.
  • Collaborate with clinical researchers, site personnel, data managers, and IT teams to implement and support clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant technologies.
  • Ensure compliance with regulatory requirements and standards (e.g., FDA, EMA, GxP, GDPR).
  • Develop IT solutions to digitize the clinical trial journey from protocol development to Clinical Study Report.
  • Provide technical support and troubleshooting for clinical applications.
  • Analyse and optimize workflows to enhance efficiency and data integrity in clinical trials.
  • Manage data integration and interoperability between different clinical and IT systems.
  • Stay updated with emerging trends and technologies in the clinical and IT fields.

Requirements:

  • Proven experience (9+ years) in IT roles within clinical research and drug development environments.
  • Strong understanding of clinical trial phases (Preclinical, Phase I-IV) and associated regulatory requirements.
  • Experience working with research/clinical datasets (including large datasets) and performing data pre-processing & feature engineering (basic level).
  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant technologies.
  • Excellent problem-solving and analytical skills.
  • Strong communication and collaboration abilities.
  • Experience with data standards such as CDISC, SDTM, and ADaM.
  • Experience working with teams using programming languages such as Python, Java, C#, SQL or JavaScript.
  • Preferred exposure to AI/ML use cases in the clinical space.
  • Familiarity with cloud computing and data security principles.

Preferred Qualifications:

  • Advanced degree in a related field.
  • Certifications in clinical research (e.g., CCRA, CCRP).
  • Experience with machine learning and artificial intelligence in clinical research.

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