EMBEDDED EXPERTS WHO
OWN AND EXECUTE.
Fill critical roles with experienced professionals who integrate directly with your teams, systems, and processes—providing the dedicated operational horsepower required to drive your programs forward.
HOW IT WORKS
Identify Your Need
Determine which role(s) you need based on your program requirements and timeline.
Match & Interview
We match you with qualified candidates. You interview and select the best fit for your team.
Onboard & Integrate
Contractor starts within 2-4 weeks, integrating with your systems, processes, and teams.
Execute & Deliver
Contractor owns and executes their function, providing regular updates and deliverables.
6-12+ months
Corp-to-Corp (C2C)
Weekly hour minimums
AVAILABLE ROLES
RBQM Lead / Manager
6-12+ monthsOwns and executes the day-to-day operations of your Risk-Based Quality Management program, serving as the central point of accountability for all RBQM activities.
Key Responsibilities:
Ideal For: Sponsors launching new RBQM programs, organizations needing dedicated program leadership, or teams requiring ongoing operational management of established RBQM systems.
Clinical Data Strategist
3-12 monthsLeads the design and implementation of clinical data strategy and governance, ensuring data assets are optimized to support risk-based approaches and regulatory compliance.
Key Responsibilities:
Ideal For: Organizations implementing centralized monitoring, sponsors needing to optimize data flows across multiple systems, or teams requiring strategic oversight of clinical data governance.
Clinical Technology Architect
3-12 monthsBridges clinical operations strategy with technical implementation, leading the design, build, and integration of systems and analytics platforms that power risk-based quality management.
Key Responsibilities:
Ideal For: Organizations implementing custom analytics solutions, sponsors needing technical leadership for platform integrations, or teams building bespoke RBQM systems.
Risk Analytics Specialist
3-6 monthsBuilds, maintains, and enhances risk monitoring dashboards and analytics tools, translating data into actionable insights for clinical teams.
Key Responsibilities:
Ideal For: Teams needing dedicated analytics support, organizations enhancing existing dashboards, or sponsors requiring ongoing signal management and reporting.
Quality Systems Specialist
3-6 monthsDevelops and maintains quality documentation and systems to ensure compliance with ICH E6(R3) and other regulatory requirements.
Key Responsibilities:
Ideal For: Organizations preparing for ICH E6(R3) compliance, sponsors needing quality documentation support, or teams preparing for audits and inspections.
PLATFORMS & TECHNOLOGIES
Our contractors have deep expertise across the clinical trial technology ecosystem, ensuring seamless integration with your existing systems.
Clinical Trial Systems
• Medidata Rave
• Veeva Vault (Clinical, Quality, RIM)
• Oracle Clinical, Oracle Argus
RBQM & Risk Analytics
• CluePoints
• Clinical Data Studio (CDS)
• Custom RiskView-style tools
Business Intelligence
• Power BI
• Tableau
• Spotfire, R-Shiny
Data Engineering & Cloud
• Microsoft Fabric, Snowflake
• AWS (Redshift, S3, Glue), Azure Data Factory
• Databricks
FREQUENTLY ASKED QUESTIONS
What's the difference between Contract Services and Consulting?
Contract Services provide dedicated, long-term resources who become an extension of your team (6-12+ months). They own and execute specific functions day-to-day. Consulting provides short-term strategic guidance, audits, and workshops (days to weeks) without ongoing operational responsibility.
How quickly can someone start?
Depending on role availability and your onboarding requirements, we can typically have a contractor start within 2-4 weeks of engagement approval. We handle all administrative aspects through our Corp-to-Corp (C2C) structure.
Can we convert a contractor to full-time?
Yes, we offer conversion options. After a minimum engagement period (typically 6 months), you can discuss conversion terms with our team. This allows you to 'try before you buy' and ensure the right long-term fit.
What if we need multiple roles?
We can provide multiple contractors simultaneously and coordinate them as a cohesive team. This is common for large RBQM implementations where you need both strategic leadership (RBQM Lead) and technical execution (Clinical Technology Architect, Risk Analytics Specialist).
How do weekly hour minimums work?
Contract roles typically require a minimum weekly commitment (e.g., 20-40 hours) to ensure continuity and effectiveness. We'll work with you to determine the appropriate level based on the role's scope and your program needs.
How Staff Augmentation Works
Needs Assessment
Define role, skills, and team fit requirements
Candidate Matching
Match expertise to your specific needs
Onboarding
Integrate with your team and systems
Embedded Work
Execute as part of your team
Knowledge Transfer
Document and hand off learnings
Needs Assessment
Define role, skills, and team fit requirements
Candidate Matching
Match expertise to your specific needs
Onboarding
Integrate with your team and systems
Embedded Work
Execute as part of your team
Knowledge Transfer
Document and hand off learnings
Related Services
Explore complementary services that work well together
Solution Delivery
Get custom RBQM analytics and dashboards built for your trial. We deliver the complete solution—you own the code.
System Analysis
Optimize your existing RBQM platform with configuration, training, and adoption strategies that ensure teams actually use the technology.
Validation
Risk-based validation (CSA), test scripts, and 21 CFR Part 11 compliance documentation for your RBQM systems.
READY TO FILL A CRITICAL ROLE?
Let's discuss your specific needs, timeline, and budget. We'll match you with qualified candidates who can start within 2-4 weeks.