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 specialist with hands-on experience in clinical risk management?

We’re looking for an RBQM Expert 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.

Reporting to the Chief Operating Officer, there is consensus that the timing is now right to appoint a Program Director to ensure the robust and commercially successful customer implementation of CluePoints enterprise software.

This role will be part of CluePoints continued growth by combining a strong customer focus with commercial understanding. One of the key indicators for success of this role is the adoption and satisfaction of customers with CluePoints solutions, which will lead to satisfied customers who continue to use, and expand the use of the CluePoints platform.

Key Responsibilities     

• Being a subject matter expert on the value and capability of the CluePoints solution and the benefits for the customer to using the platform
• Being able to articulate those benefits at every level, from the individual trial manager up to the head of R&D in global pharmaceutical companies
• Identifying stakeholders and understanding what will mutually benefit their needs and CluePoints
• Working across multiple customers to ensure the successful and impactful adoption of CluePoints software solutions
• Being structured, rigorous, data driven and most importantly proactive in managing large complex, multi stakeholder customers, understanding how to push and leverage the customer’s change management efforts
• Providing oversight and leadership to project managers to ensure the successful deployment, adoption and longterm success of the CluePoints customer base
• Collaborating with the larger CluePoints team during implementation and ramp-up activities to ensure alignment with Customer Success, Project Management and Business Development as needed
• Utilizing knowledge of how software solutions are implemented within the confines of Pharmaceutical regulations to play a key role in identifying solutions and navigating the challenges of implementation (e.g., disparate systems, variety of external data sources, validation protocols) cross functionally
• Strategically creating the overall plan to successfully implement assisting project managers with understanding the vision to incorporate correct project plans
• Being the voice of the customer back into the CluePoints organization. As someone who will be close to the customer and experiencing the most valuable elements of the product, opportunities for improvement and frustrations where they exist
• Gain respect as an internal expert in enterprise software implementation helping to grow the expertise within the project management discipline and across professional services

Experience

• Previous experience in the deployment of SaaS solutions in a complex, multi-stakeholder environment
• Commercially focused leader who can map their actions onto current or future customer retention and growth for the company
• Client-facing with excellent stakeholder management skills at all levels, from senior decision-makers to individual trial managers
• Strong understanding of clinical trials, ideally clinical trials’ technology (eCOA, IRT and similar solutions)
• Experience of balancing a portfolio of client accounts and being able to manage their time accordingly
• Experience of building strong and scaleable processes to enable teams to be more efficient and deliver a better customer experience
• Happy to work in a high-growth environment
• Highly analytical, able to create and use management information which will allow the business to understand customer adoption
• Collaborative team player who will be able to engage internally with key stakeholders including project managers, customer success and the technology team
• Experience in mentoring and guiding project managers

Location

This is an important leadership role. Whilst the position provides some remote working, individuals will need to be located in the UK, US (East Coast), Belgium, or Poland. Ideally, the person will be able to engage with team members face to face at regular intervals.

CluePoints is an innovative and  fast-growing company and the premier provider of Risk-Based Quality Management and Data Quality Oversight solutions to clinical research organizations. We are looking for Senior IT Support Engineer to join our team. 

RESPONSIBILITIES

•  Installing, configuring and maintaining the network, computers and business tools including hardware, system software, data storage, applications and VoIP telco.
• Sustaining network integrity and security (internal backups, access controls, VPN IPSEC connection, firewalls and intrusion detection systems…).
• Diagnosing and resolving hardware, software, networking, and system issues and outages when they arise.
• Replacing and upgrading defective or outdated components when necessary.
• Monitoring system performance to ensure everything runs smoothly and securely.
• Researching and recommending new approaches to improve the networked computer and cloud-based server system while anticipating prerequisites, consequences and side effects.
• Providing technical support when requested.
• Documenting IT infrastructure, assets, software implementation and any processes which employees need to follow in order to successfully work within our computing system.
• Set up employee accounts and IT requirements.

QUALIFICATIONS

• Excellent knowledge of IT systems (Windows, Linux, Mac) and infrastructure 
• Knowledge of:
• Microsoft Entra ID
• Office 365
• Atlassian (Jira, Confluence)
• Professional certification or completed training programs are a plus. 
• Prior experience in corporate IT support roles (e.g., IT Support Engineer, Support Officer) with a strong focus on end-user support and service desk operations.
  
• Prior experience with networks, databases and patch management. 
• Strong knowledge of security issues and ways to prevent them. 
• Knowledge of the best practices, software and processes in the industry. 
• Excellent problem-solving aptitude and analytical skill. 
• Ability to prioritize a wide range of workloads with critical deadlines and manage an IT project from end to end.
• Able to evolve in a fast-moving environment and bring innovative thinking.
• High degree of accuracy and attention to detail.
• Team player.
• Strong communication skills. 
• Excellent English oral and written communication skills.
• Bachelor's degree in computer science, information technology or related fields, or equivalent relevant experience.

SKILLS AND COMPETENCES

• OS: Windows, MacOS and Linux.
• Infrastructure: Azure cloud, Intune, Jamf, Ubuntu Landscape
• Networking: Firewall, VPN/ZTNA, IPSEC, Switch, DNS, DHCP & Meraki WIFI installation, configuration and administration
• Atlassian

REASONS TO JOIN US 

• Flexibility is part of our DNA
• Hybrid with 2-3 days in office per week 
• Our offices provide a fun atmosphere: PS4, foosball, and our newly added dartboard
• Many activities are organized during the year such as team lunches, happy hours, team buildings, holiday parties and many other celebrations! 
• At CluePoints, learning, training and personal growth are part of the game: you’ll have access to online training materials, certifications sponsored by the company, personal growth plans, and career paths to explore new opportunities.
• You’ll work with a fast-growing, multi-disciplinary and international team representing over 20 different nationalities, in an English-speaking working environment.
• You’ll have a challenging and rewarding job in an ambitious and fast-paced technology scale-up that has received many national and international awards including “Scale-Up of the year 2019”!
• Last but not least, we offer competitive salary and benefits, bonus potential, employee referral program.

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