Enterprise Solution Architect for E-Protocol System

Hi,

Please go through the below requirements and let me know your interest and forward your resume along with your contact information to raja@covetitinc.com

Role : Enterprise Solution Architect for E-Protocol System/Solution Architect for E-Protocol System

Location : Wilmington, MA or Boston, MA (Remote with occasional travel)

Duration : Contract - Long Term

Job description:

Health Care domain is a plus

Must be very strong communicators with deep technical skills.

We are collaborating with Charles River Laboratories (CRL) on a critical project to design and document the requirements for their new E-Protocol platform. This system will replace today’s static Word/PDF-based study protocols with a metadata-rich, structured record that can flow into downstream systems and support automation across study setup, quality control, and regulatory submission. We need a US-based senior technical architect to lead solution design efforts in partnership with the consulting team and CRL’s digital/IT stakeholders. The role requires both strategic design capability and hands-on architecture skills.

Key Responsibilities:

1. Lead the end-to-end solution architecture for the E-Protocol platform, ensuring it can capture structured protocol data and drive automation across the study lifecycle.
2. Translate business pain points (manual drafting, inconsistent templates, heavy rework, fragmented tools) into technical requirements and design patterns.
3. Define system integrations between E-Protocol and downstream applications through APIs, event-driven messaging, and canonical data models.
4. Design supporting services such as rules validation, terminology/vocabulary management, scheduling logic, and automated quality checks.
5. Ensure the architecture supports compliance, auditability, data lineage, and traceability in a regulated environment.
6. Collaborate with the client’s IT/Digital team to align the E-Protocol solution with in-flight digital initiatives and long-term enterprise architecture standards.

Required Skill Set:

1. Deep experience in enterprise and solution architecture, ideally in complex, regulated industries.
2. Hands-on expertise with event-driven and workflow orchestration platforms (e.g., Camunda, Pega, Decisions, or equivalent) in a Microsoft-based environment.
3. Strong knowledge of API integration, canonical data models, and data orchestration across multiple applications.
4. Experience with document and content management systems that use metadata and templates to generate structured content.
5. Familiarity with rules engines, terminology services, and data validation frameworks.
6. Background in data integrity and compliance for highly regulated environments (life sciences, healthcare, financial services, or equivalent).
7. Proven ability to lead solution workshops, produce design artifacts, and partner with both technical teams and business stakeholders.

Thus, the project involves someone with following strong skills

1. Integration and Ingestion –
2. Creation of an integration framework to accept the different formats (unstructured, API, xls, pdf, txt)
3. Do conversion to a standard internal format (eg. use AI)
4. Track the metadata for the study in a standardized manner
5. Workflow – Define a workflow to track the end-to-end processes (Submission to getting back results).
6. Each section of the Study may be handled by a different approving team/department.
7. Escalation/Timeouts
8. Resubmission – Define process to track and resubmit (deviation, amendment, revert back from earlier stages/flow) a study when values/requirements change
9. Validation Rules engine - enforce/compliance
10. Governance/Data Management – Standardization of fields and terminology (create a MDM, Glossary and source of truth system)
11. Audit Trail – Define a audit framework to track every stage of the process
12. Decision Making - Drive team consensus on tooling, processing
13. Documentation – Creating technical artifacts C4/UML etc, DB diagramming tools

Please keep in mind that candidates COMMUNICATION SKILLS MUST BE VERY GOOD.

Between, we had gathered the following details for the offshore data analysts & data engineers’ requirements which provides little bit of technology being used at CRL

1. Power BI, Azure, UAT, data analysis, stakeholder mgmt
2. DevOps, SQL, Python, Spark, RESTful services
3. Data Bricks, Python, scientific report writing