Clinical Technology Solution Architect (CTSA)

Greetings from IT Engagements…!

IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.

Job Title: Clinical Technology Solution Architect (CTSA)

Location: Framingham, MA, Local to MA/RI/NH (Hybrid - Onsite once a week as needed)

Job Type: Long Term Contract

Experience: 10 years as a Solution Architect, 10 years in Pharma/Biotech industry

Job Summary:

The Clinical Technology Solution Architect (CTSA) is responsible for designing and implementing clinical technology solutions that optimize clinical workflows, enhance patient outcomes, and improve operational efficiencies within Pharma/Biotech organizations. This role ensures seamless integration of clinical technologies, compliance with regulatory standards, and alignment with organizational goals. The CTSA collaborates closely with clinicians, IT teams, and key stakeholders to develop scalable, secure, and efficient solutions that support clinical research and trials.

Key Responsibilities:

• Solution Design & Implementation: Architect and deploy clinical technology solutions, ensuring alignment with business objectives and regulatory compliance.
• System Integration: Develop and oversee the integration of technologies such as EDC, CTMS, eCOA, ePRO, and data analytics tools into clinical workflows.
• Regulatory & Compliance Adherence: Ensure solutions comply with FDA, HIPAA, GxP, GDPR, and other industry standards to maintain data security and patient confidentiality.
• Stakeholder Collaboration: Work closely with clinical teams, IT departments, vendors, and executive leadership to gather requirements and deliver impactful solutions.
• Innovation & Modernization: Lead HIT system transitions, large-scale implementations, and modernization initiatives in clinical environments.
• Data Management & Analytics: Oversee data governance, interoperability, and reporting to enhance decision-making and clinical trial effectiveness.
• Technical Leadership: Provide guidance to engineering teams and solution architects, ensuring best practices and innovative technology adoption.
• Risk Assessment & Security: Identify potential risks in clinical technology deployments and implement security protocols to protect sensitive data.

Required Qualifications:

• 10 years of experience as a Solution Architect, with a strong focus on clinical technology solutions.
• 10 years of pharma/biotech industry experience, preferably in clinical research or life sciences environments.
• Hands-on experience with EDC (Electronic Data Capture), CTMS (Clinical Trial Management Systems), eCOA (Electronic Clinical Outcome Assessments), ePRO (Electronic Patient-Reported Outcomes), and clinical analytics.
• Deep understanding of clinical workflows, regulatory requirements, and healthcare interoperability standards.
• Strong expertise in cloud platforms (AWS, Azure, or GCP), API integrations, and enterprise IT architectures.
• Familiarity with HL7, FHIR, CDISC, SDTM, and other healthcare data exchange standards.
• Experience leading large-scale clinical technology implementations or system modernization projects.
• Excellent communication and collaboration skills, with the ability to engage both technical and non-technical stakeholders.

Preferred Qualifications:

• Experience working with AI/ML in clinical technology solutions.
• Prior experience in clinical/life sciences IT transformations.
• Certifications in clinical informatics, healthcare IT, or cloud architecture.

Thanks and Regards

Shashank Jaitly

Shashank@itengagements.comwww