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

Orion Corporation; Cambridge; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Orion Pharma seeks a Clinical Risk Manager to lead RBQM across global studies, guiding central monitoring and risk management with cross-functional teams. You will drive quality, compliance, and patient safety in Orion's development programs.

The role requires expertise in central monitoring, ICH/GCP familiarity, and strong analytical skills to interpret KRIs and trends across studies.

Qualifications

• Minimum bachelor’s degree with biotechnology/pharma industry experience or equivalent.
• Proven expertise in central monitoring and RBQM implementation.
• Strong analytical and communication skills for cross-functional teams.

Responsibilities

• Lead cross-functional study teams in RBQM-related startup activities and monitoring strategy.
• Develop and author the Clinical Trial Risk Management Plan.
• Act as SME for RBQM system configuration, implementation, and execution.
• Provide leadership and training on RBQM issues within Central Monitoring.
• Conduct and communicate study-level central monitoring reviews using data tools.
• Interpret KRIs/QTLs and trends to guide sponsor actions and study decisions.

Skills

Central Monitoring

RBQM knowledge

Leadership

Regulatory knowledge

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Tools

RBQM systems

Analytical tools

Job description

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

Cambridge, United Kingdom and 1 more (Hybrid)

Job Description

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 solving/critical thinking abilities and experience
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and regulations

Emotional skills and abilities/qualities:

• Effective communication and interpersonal skills; ability to build relationships internally and externally
• Confident and articulate communication skills (both written and verbal), with the ability to convey and present highly complex information to others clearly and logically
• Leadership skills including the ability to work within a multidisciplinary team environment and influence adoption of RBQM concepts
• High quality standards and attention to detail
• Aptitude for mathematical concepts, statistical concepts, and data analytics
  

#LI-ORION

Your new team

Orion's pharmaceutical innovations are created within its R&D organization. We employ over 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Nottingham and Cambridge in the UK, and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas.

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We are home to more than 4,000 Orionees around the world, and we are proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.

• Locations The Bennett building B930 Babraham Research Campus, Cambridge, CB22 3AT, GB One Broadway, Cambridge, Massachusetts, 02141, US (Hybrid)