Reveille Technologies - eTMF Solution Architect

eTMF Solution Architect (FTE).

Location : Pan India

Exp : 12- 14 Years.

Notice : Immediate30 Days (serving only).

Domain : Life Sciences / Clinical / R&D.

Role Overview :

The eTMF Solution Architect will be responsible for designing, implementing, and governing end-to-end eTMF (Electronic Trial Master File) solutions to support Clinical Operations within a regulated Life Sciences environment. This role involves driving architectural decisions, ensuring regulatory compliance, leading integrations, and collaborating with cross-functional teams to enable efficient clinical trial documentation management.

Key Responsibilities :

- Architect, design, and deliver scalable end-to-end eTMF solutions across global clinical programs.

- Define system architecture, data models, workflows, configurations, and security frameworks for eTMF platforms.

- Develop architecture blueprints, design standards, integration patterns, and best practices for eTMF systems.

- Translate business needs into technical requirements and solution design documents.

- Integrate eTMF with clinical systems such as CTMS, EDC, Safety Systems, Regulatory platforms, and Quality systems.

- Work with APIs, web services, and middleware to build seamless data flow.

- Ensure secure data exchange, identity management, and access controls in alignment with compliance standards.

- Guide technical teams during implementation, configuration, and migration activities

- Ensure all eTMF solutions comply with ICH-GCP, 21 CFR Part 11, GxP, GDPR, and TMF Reference Model guidelines.

- Lead governance activities, design reviews, process audits, and quality checks.

- Oversee Computer System Validation (CSV), SDLC documentation, risk assessments, and audit readiness.

- Establish SOPs, standards, and documentation frameworks to support regulatory audits.

- Collaborate with Clinical Operations, Quality, Regulatory, IT, and vendor teams to align solution design with business goals.

- Lead cross-functional workshops, requirement-gathering sessions, and technical discussions.

- Manage vendor relationships, assess solution feasibility, and evaluate new capabilities or enhancements.

- Mentor technical teams and support continuous improvement initiatives.

- Lead data migration strategy, mapping, and validation for legacy-to-new eTMF transitions.

- Ensure quality, usability, and completeness of migrated documents and metadata.

- Support deployment planning, user acceptance testing (UAT), and post-production stabilization.

Required Expertise :

- Strong hands-on experience with leading eTMF platforms such as Veeva Vault eTMF, PhlexTMF, Wingspan, MasterControl, or similar systems.

- Deep understanding of TMF Reference Model, Clinical Trial documentation processes, and regulatory expectations.

- Proficiency in integrations, APIs, identity management, and cloud infrastructure (AWS/Azure).

- Extensive experience with CSV, system audits, documentation, and compliance frameworks.

- Strong analytical, architectural design, and problem-solving skills.

- Excellent communication and stakeholder management skills.

- Strong documentation skills, including design documents, standards, and validation deliverables.

- Ability to lead cross-functional teams and manage multiple priorities.