About Us: 

We are a rapidly expanding, innovation-driven company in the e-clinical space, setting new standards in data quality and patient safety for clinical trials. Our cutting-edge, AI-powered solutions empower our clients—leading pharmaceutical companies and CROs worldwide—to integrate Risk-Based Quality Management (RBQM) practices seamlessly, optimizing trial outcomes while maintaining compliance with industry standards.

The Opportunity: 

Are you a seasoned RBQM expert with hands-on experience in clinical risk management?

We’re looking for an RBQM Deployment Advisor to deliver high-impact guidance and expertise, helping our clients implement and enhance RBQM processes tailored to their specific needs. This role is an opportunity to influence the future of clinical research by applying your RBQM skills in consultations, protocol reviews, and practical, client-centered training.

If you’re passionate about advancing RBQM and driving real change in the clinical field, this is the role for you!

What You’ll Do:

· Deliver Expert RBQM Consultation: Lead detailed consultations with clients, conducting risk assessments and offering data-driven recommendations that enhance trial quality.

· Guide Protocol and Process Improvement: Provide technical insight in reviewing client protocols and implementing RBQM best practices across studies.

· Collaborate on Product Development: Work closely with internal teams to provide feedback that shapes our products and ensures alignment with RBQM standards.

· Develop Educational Resources: Create materials and tools that support clients in their RBQM journey, reinforcing industry-leading practices.

What You Bring:

· RBQM Expertise: At least 5 years of experience in RBQM-focused clinical research, with proven skills in risk assessments, critical-to-quality identification, and data-driven risk management.

· Analytical Precision: A sharp eye for detail with a strong analytical approach to interpreting data and managing risks.

· Industry Knowledge: In-depth understanding of clinical trial processes, study phases, and RBQM requirements across therapeutic areas.

· Collaborative Communication: Excellent verbal and written communication skills for both internal and client interactions.

· Driven by Impact: Comfortable in a high-growth, innovative environment where your expertise will have a tangible impact on the future of clinical research.

Why Join Us?

· Innovative Culture: Work at the forefront of e-clinical solutions, helping shape the industry’s approach to data quality and patient safety.

· Expert Community: Join a team of highly skilled professionals who value collaboration, growth, and expertise.

· Meaningful Work: Drive real improvements in clinical trial outcomes, supporting clients in adopting industry-leading RBQM practices.

Ready to Make an Impact? If you’re a dedicated RBQM specialist ready to elevate the future of clinical research, we’d love to hear from you! Apply today to be part of a team that’s transforming RBQM in the pharmaceutical industry.

SCOPE:

The Platform Analyst will support clients to ensure their RBQM related business requirements are achieved during the implementation of the CluePoints Platform through gap analysis, process definition and recommended solutions. 

This Platform Analyst understands emerging technologies and can identify opportunities to automate and standardize business processes. They assist with educating the Product team on the client’s business requirements and assists with facilitating communication and alignment between functions and Product from the gathering of initial requirements to final implementation. This Analyst may also be responsible for the development of business and technical process documentation and training materials.

Maintaining excellent communication, attention to detail and establishing strong relationships are keys to success in your interactions with colleagues from within other CluePoints departments as well as externally with our clients.

RESPONSIBILITIES:

• Developing and maintaining documentation to support the Business Analyst Services which are provided both internally and externally
• Understanding and evaluating current business processes in the context of the integration of the CluePoints platform modules into the customer’s ecosystem (i.e., CTMS integration, SSO integration, Usage Dashboard, Connectors, Validation)
• Identifying, evaluating and developing recommendations and procedures that foster the successful integration of CluePoints platform modules
• Support the successful operational and technical integration of CluePoints platform modules into the customer’s ecosystem by:
  o providing leadership and consultation in planning and executing integration
  o supporting the collection of business requirements and definition of functional specifications
  o collaborating with the Operational Project Manager to ensure successful execution of tasks and objectives
• Develop and maintain implementation frameworks for all CluePoints modules
• Participate in the continuous improvement and development of our product solutions and operational processes by acting as a Subject Matter Expert
• Support Business Development in pre-sales activities
• Support Customer Success in platform integration by defining applicable process implementation strategies as well as identification of areas of risk or limitations for a successful CluePoints implementation
• Acquiring a deep understanding of existing systems/platforms
• Capturing business needs and supporting the research of potential new solutions to business needs
• Presenting ideas and observations in meetings
• Collaborating with end users and stakeholders across Product and Business functions
• Contributing a steady stream of creative, out-of-the-box thinking in support of innovation and problem solving

REQUIREMENTS:

• Bachelor's Degree or equivalent, in Information System, Computer Science, Business, or other related fields
• 5+ years of relevant work experience working in SaaS environment with a background in consulting
• Experience with project leadership in a clinical development environment
• A customer-mindset including excellent empathy skills in order to better understand your audience
• Above average understanding of the requirements of working in a regulated environment (i.e., ICH, FDA, EMA, MHRA)
• Effective English verbal and written communication skills including the ability to relay information both internally and externally
• Ability to ask the right questions to surface essential information
• Good understanding of software implementation, software validation and RBQM methodologies
• Advanced analytical skills including the ability to document analysis of current and future states
• Ability to create documentation that is levelled for both business and technical users
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Works independently with an ability to multi-task and provide expertise on multiple projects concurrently
• Ability to thrive in a fast-moving environment, under time and resource constraints
• Comfortable working globally across multiple time zones
• Up to 10% travel domestically & internationally