Senior Clinical Solutions Architect

6 days ago


Bengaluru, Karnataka, India Winning Edge Full time
Unlock Career Growth with Winning Edge

Are you a seasoned professional seeking new challenges in the clinical research and drug development space? Do you possess a strong background in IT, clinical trials, and data management? If yes, we invite you to explore this exciting opportunity as a Senior Clinical Solutions Architect at Winning Edge.

About the Role:
  • We are looking for a highly skilled individual to lead our clinical technology team and drive innovation in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant technologies.
  • The ideal candidate will have 9+ years of experience in IT roles within clinical research and drug development environments, with a strong understanding of clinical trial phases (Preclinical, Phase I-IV) and associated regulatory requirements.
Key Responsibilities:
  1. Partner with clinical business stakeholders to optimize and transform using tech solutions.
  2. Act as domain lead and represent the clinical tech team in discussions with clinical business teams.
  3. Be an advocate of the data science vision of the tech team to introduce breakthrough innovations and cater to efficiency gains.
  4. Work with Engineering team to design, develop, and maintain IT systems and applications used in clinical research and drug development.
  5. 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.
  6. Ensure compliance with regulatory requirements and standards (e.g., FDA, EMA, GxP, GDPR).
  7. Develop IT solutions to digitize the clinical trial journey from protocol development to Clinical Study Report.
  8. Provide technical support and troubleshooting for clinical applications.
  9. Analyse and optimize workflows to enhance efficiency and data integrity in clinical trials.
  10. Manage data integration and interoperability between different clinical and IT systems.
  11. 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.
Salary Range:

$120,000 - $180,000 per annum, depending on experience.

Join Our Team:

We offer a dynamic work environment that fosters growth, innovation, and collaboration. If you're passionate about driving change in the clinical research and drug development space, submit your application today



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