Tilda Research is hiring for 2 clinical research roles focused on site support, clinical technology, and TMF operations.

1. Site Support Specialist — Clinical Research

Work Mode: Remote
Working Hours: US East Coast hours

Role Overview

The Site Support Specialist will support clinical research sites using the Tilda platform. The role combines clinical research operations, site support, customer service, training, troubleshooting, and product collaboration.

Key Responsibilities

• Support Clinical Research Coordinators, Investigators, Site Managers, and regulatory teams.
• Build protocol-specific eSource for assigned sites.
• Assist with document collection and filing during study startup.
• Resolve site workflow and product-support issues.
• Troubleshoot user workflow, training, configuration, permissions, data, and product issues.
• Reproduce and document issues before escalation to Product or Engineering.
• Provide practical workarounds where appropriate.
• Support study startup, recruitment, screening, patient visits, data collection, regulatory activities, study conduct, and closeout.
• Train new sites and users on the Tilda platform.
• Create FAQs, user guides, training materials, and support documentation.
• Communicate recurring site feedback and workflow challenges to Product and Engineering.
• Participate in testing new product features.
• Identify opportunities to improve workflows, automation, training, and user experience.

Required Qualifications

• 2+ years of experience in clinical research, clinical trial operations, site operations, or a related function.
• Experience with data entry and creating eSource is required.
• Experience working directly with clinical research sites or site-based clinical teams.
• Strong understanding of clinical research site workflows.
• Experience working with CRCs, Investigators, Site Managers, or similar stakeholders.
• Experience using or supporting clinical trial technology/software platforms.
• Strong communication and customer-service skills.
• Structured troubleshooting and problem-solving ability.
• Strong organizational skills and attention to detail.

Preferred Experience

Experience with:

• Medidata
• Veeva
• Florence Healthcare
• Oracle Clinical
• IQVIA clinical technologies
• Signant Health
• Clario
• TrialKit
• CTMS
• EDC
• eRegulatory/eISF
• eConsent
• Patient recruitment or clinical workflow platforms

2. TMF Specialist

The TMF Specialist will be responsible for eTMF completeness, accuracy, quality, and inspection readiness across assigned clinical studies.

Key Responsibilities

eTMF Reviews & Inspection Readiness

• Perform periodic and milestone eTMF completeness reviews in Veeva Vault.
• Conduct cross-check and co-dependency verification.
• Identify and resolve missing or incorrect documents.
• Maintain inspection readiness across assigned studies.
• Update the Expected Document List (EDL) as requirements change.

Quality & Compliance

• Perform ALCOA+ and metadata checks.
• Validate document types, properties, indexing, and scanning quality.
• Ensure documentation meets GCP and internal SOP requirements.

Collaboration & Issue Resolution

• Work with Study Teams, TMF Leads, Document Owners, and TMF Study Owners.
• Follow up on document queries and outstanding actions.
• Resolve discrepancies within agreed SLAs.
• Escalate risks and issues when required.
• Provide guidance on corrective actions.

Training & Continuous Improvement

• Process TMF documents according to good documentation practices and study priorities.
• Conduct training and office hours for internal teams.
• Respond to TMF process and system questions.
• Contribute to process improvement initiatives.
• Support special projects and act as a TMF SME where applicable.

Required Qualifications

• 2–3 years of experience in TMF/eTMF operations within a CRO, sponsor, or TMF service provider.
• Hands-on experience with Veeva Vault eTMF or a similar eTMF platform.
• Experience with document ingestion, indexing, QC, and reporting.
• Strong knowledge of ICH-GCP, ALCOA+, and TMF Reference Model concepts.
• Experience conducting completeness reviews.
• Experience managing EDL updates and inspection readiness.
• Strong attention to detail and stakeholder-management skills.
• Ability to manage multiple studies and work against SLAs.

Preferred Qualifications

• Experience across Phase I–IV studies.
• Experience across multiple therapeutic areas.
• TMF SME or trainer experience.
• Experience developing SOPs or work instructions.
• Familiarity with TMF metrics and dashboards.
• Experience supporting audits or regulatory inspections.
• Exposure to eCTD, QMS, ETMF reporting, or BI tools.

Tools & Systems

• Veeva Vault eTMF
• Excel/Google Sheets
• eTMF reporting and metrics tools
• QMS
• eCTD concepts

Key Performance Indicators

• eTMF completeness
• Quality error rate
• On-time document processing
• Open query/action-item aging
• Internal QC/audit findings
• Regulatory inspection findings
• Training adoption and stakeholder satisfaction

About Tilda Research

Tilda Research is developing AI-native tools and AI teammates for clinical research operations. Its technology is designed to help sponsor, CRO, and research teams simplify study management, improve data quality, support real-time oversight, and accelerate clinical trial timelines.

The company operates at the intersection of healthcare, clinical research, technology, and AI, with a focus on reducing administrative bottlenecks while supporting clinical research teams and patients.

How To Apply

Application Link For TMF Specialist

Application Link For Site Support Specialist — Clinical Research