Clinical Business Integration Specialist

3 weeks ago

Bangalore, India Winning Edge Full time
Key Responsibilities:

Partner with Clinical Stakeholders: Collaborate with clinical business stakeholders to identify opportunities for optimizing and transforming clinical research processes using technology solutions.

Domain Lead and Representation: Act as a domain lead and represent the clinical technology team in discussions with clinical business teams, ensuring effective communication and alignment of goals.

Advocate for Data Science Vision: Be an advocate for the data science vision of the tech team, introducing breakthrough innovations and driving efficiency gains in clinical research.

IT System Development and Maintenance: Work with the Engineering team to design, develop, and maintain IT systems and applications used in clinical research and drug development, ensuring compliance with regulatory requirements and standards.

Clinical Trial Management: 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, ensuring seamless data integration and interoperability.

Regulatory Compliance: Ensure compliance with regulatory requirements and standards, such as FDA, EMA, GxP, and GDPR, to maintain the highest level of data integrity and security.

Technical Support and Troubleshooting: Provide technical support and troubleshooting for clinical applications, ensuring timely resolution of issues and minimal disruption to clinical research operations.

Workflow Analysis and Optimization: Analyze and optimize workflows to enhance efficiency and data integrity in clinical trials, identifying areas for improvement and implementing effective solutions.

Data Integration and Interoperability: Manage data integration and interoperability between different clinical and IT systems, ensuring seamless data exchange and minimizing data loss or corruption.

Emerging Trends and Technologies: Stay updated with emerging trends and technologies in the clinical and IT fields, applying this knowledge to drive innovation and improvement in clinical research operations.

Requirements:

Experience: Proven experience (9+ years) in IT roles within clinical research and drug development environments, with a strong understanding of clinical trial phases and associated regulatory requirements.

Skills and Qualifications: Strong problem-solving and analytical skills, excellent communication and collaboration abilities, proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant technologies, experience working with research/clinical datasets, and performing data pre-processing & feature engineering.

Preferred Qualifications: Advanced degree in a related field, certifications in clinical research (e.g., CCRA, CCRP), and experience with machine learning and artificial intelligence in clinical research.

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