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

Cambridge, United Kingdom and 1 more (Hybrid)

We are looking for a 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:

• To manage and execute the Risk Based Quality Management processes and day-to-day activities related to Orion’s propriety products development portfolio in conformance to all relevant law, regulations, guidelines, policies and procedures.
• To be the subject matter expert for Central Monitoring RBQM systems.
• Accountability for centralised monitoring activities across a number of global studies, analytical data review of key risk and presenting as an integral member of the Clinical Study Team. The reviews include interpretation of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs) available through an analytical tool as well as comprehensive review of supplemental operational data/trends and issues to be interpreted, reported, and presented to the study teams.
• This role will lead, contribute, and drive continued process improvement and innovation activities, and industry collaboration in central monitoring capabilities.

Responsibilities

• Lead the cross-functional study team in the completion of RBQM-related study start-up processes, such as protocol de-risking, Risk assessment and categorisation, and input into the monitoring strategy (SDV targets) whilst keeping RBQM concepts central to all study activities.
• Responsible for development and authoring activities of the Clinical Trial Risk Management Plan.
• Act as a subject matter expert for the configuration, implementation, and execution of RBQM system across studies.
• Provide leadership, operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related to RBQM system.
• Conduct & communicate study-level central monitoring review for assigned studies using data analysis tools.
• Interpret the relationships between each KRIs/metric and any supporting data to critically assess trends within a site/study.
• Review, interpret and report data as an integral part of the Clinical Study Team in support of identifying centralised monitoring activities and/or investigator sites potentially requiring sponsor intervention.
• Support study teams in understanding the impact, criticality and potential root causes of the findings and defining appropriate follow-up actions.
• Document the output from Central Monitoring review meetings and track decisions/actions to closure.
• Contributes to the ongoing development of the RBQM model and related processes.
• Participates in ongoing improvements in standardizing systems, documentation, processes, and training materials that supports RBQM activities.
• Represents RBQM in process improvement initiatives.
• Assign and delegate appropriate RBQM tasks to Data Analyst / programmer.
• May support activities to enhance existing analytical tools.
• May perform other work-related duties as assigned.

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 or equivalent.

Technical skills and abilities:

• Central Monitoring, site monitoring or data management experience
• Knowledge and experience with clinical databases, systems, electronic data capture systems, quality control processes, and auditing procedures
• Working 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
• Analytical problem…