Senior Clinical Risk Manager, RBQM, R&D, Orion Pharma

Senior Clinical Risk Manager, RBQM, R&D, Orion Pharma

Cambridge, United Kingdom and 1 more (Hybrid)

Job Description

We are looking for a Senior Clinical Risk Manager to play a key role in advancing Orion's global development portfolio through Risk Based Quality Management (RBQM). In this strategic position, you will lead central monitoring activities, provide expert guidance on clinical risk management, and partner with cross-functional teams to ensure the highest standards of quality, compliance, and patient safety across our clinical studies.

Your role

In this role, you will:

• Provide leadership and oversight in the management and execution of Risk Based Quality Management (RBQM) processes, ensuring robust governance across Orion's proprietary products development portfolio in conformance to all relevant law, regulations, guidelines, policies, and procedures.
• Serve as the senior subject matter expert for Central Monitoring RBQM systems, championing innovation and best practices at the operational level.
• Accountability overseeing centralised monitoring activities across multiple global studies, providing advanced analytical data review of key risks, and acting as a strategic advisor within the Clinical Study Team. Senior reviews include interpretation of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs) via analytical tools, as well as high-level evaluation of operational data, trends, and complex issues to be interpreted, reported, and presented to study teams and senior stakeholders.
• This role will lead, contribute, and drive continued process improvement and innovation activities, and industry collaboration in central monitoring capabilities, with a particular focus on mentoring junior staff and influencing cross-functional teams.

Responsibilities

• Lead and provide senior guidance to cross-functional study teams in the completion of RBQM-related study start-up processes, including protocol de-risking, risk assessment and categorisation, and input into monitoring strategy (SDV targets), with a focus on embedding RBQM principles across all study activities.
• Act as the primary point of contact for bid defence activities, representing Clinical Risk Management in meetings and discussions with clients and stakeholders, and ensuring comprehensive and informed responses to queries throughout the bid process.
• Oversee the development, authoring, and review of Clinical Trial Risk Management Plans, ensuring alignment with organisational goals and regulatory requirements.
• Act as the senior subject matter expert for the configuration, implementation, and execution of RBQM systems across studies, providing strategic direction and technical oversight.
• Provide leadership, operational expertise, advanced training, and mentorship, serving as the primary point of escalation for complex Central Monitoring issues related to RBQM systems.
• Conduct & communicate study-level central monitoring review for assigned studies using data analysis tools.
• Interpret relationships between KRIs/metrics and supporting data to critically assess trends within sites/studies, providing strategic recommendations for risk mitigation.
• Review, interpret, and report data as a senior member of the Clinical Study Team, supporting the identification of centralised monitoring activities and/or investigator sites potentially requiring sponsor intervention, and advising on escalation protocols.
• Support study teams in understanding the impact, criticality, and potential root causes of findings, defining appropriate follow-up actions, and ensuring effective implementation across studies.
• Document outputs from Central Monitoring review meetings, track decisions/actions to closure, and ensure robust documentation practices are followed throughout the team.
• Drive the ongoing development of the RBQM model and related processes, contributing expert insight and strategic direction to process improvement initiatives.
• Lead and participate in ongoing improvements to standardising systems, documentation, processes, and training materials that support RBQM activities, ensuring consistency and quality across the organisation.
• Represent RBQM in high-level process improvement initiatives and cross-functional meetings, providing strategic input and championing best practices.
• Assign, delegate, and oversee appropriate RBQM tasks to Data Analysts/programmers, providing guidance, feedback, and development opportunities.
• Lead activities to enhance existing analytical tools, driving innovation and improvement in data analysis capabilities.
• Perform other senior work-related duties as assigned, contributing to the broader success of the Clinical Risk Management division.

What you can expect from us

At Orion Pharma, your work impacts millions of lives around the world. With us, you get to work on challenges that matter and see the difference your work makes every day. We believe our people are the key to our success, which is why we invest in your continuous learning.

Our innovative products are world-class, and we take sustainability and ethics seriously. Rooted in our Nordic heritage, we value teamwork, low hierarchies, and a culture where every voice is heard.

We are builders of well-being and offer jobs with a clear purpose: helping people live their lives to the fullest.

• Minimum bachelor's degree and significant relevant biotechnology/pharmaceutical industry experience.
• Significant experience in Clinical Risk Management and RBQM systems
• Strong understanding of regulatory requirements and clinical governance framework

Technical skills and abilities:

• Extensive Central Monitoring, site monitoring or data management experience
• Extensive knowledge and experience with clinical databases, systems, electronic data capture systems, quality control processes, and auditing procedures
• Proven knowledge in system development
• Ability to operate and proactively use various systems and databases to analyse risk related to trial quality/performance and compliance and identify trends and early warning signals
• Excellent analytical problem solving/critical thinking abilities and experience