Orion Corporation
Study Monitoring Lead, Clinical Operations, Oncology Therapy Area, R&D, Orion Corporation
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Study Monitoring Lead (SML)
The Study Monitoring Lead (SML) is accountable for the day-to-day operational oversight of clinical trial execution, with a strong focus on study feasibility activities, site management, and monitoring oversight.
The SML provides hands-on oversight of daily trial activities to ensure consistent, high-quality execution in line with the study protocol, the study plans, timelines, regulatory requirements, and operational expectations.
Responsibilities
Study Feasibility & Site/Country Selection Oversight
- Contribute to and oversee study feasibility activities, including assessment of country and site capabilities, patient access, and operational considerations.
- Provide input and oversight to support optimal country and site selection to enable successful study execution in collaboration with the Clinical Study Manager, Clinical Study Physician, other study team members, and CRO/service providers as applicable.
Site Set Up and Management Oversight
- Closely monitor site activation performance, ensuring that all study activities (including IMP supplies, lab kits, site agreements, regulatory documents, etc.) are anticipated to ensure timely site activation.
- Ensure site enrollment, data quality, and protocol adherence.
- Prepare, review, or validate clinical study plans related to site management, end-to-end sample flow, and other study manuals as applicable (e.g., Study monitoring plans, Laboratory manuals, etc.).
- Prepare, review, or validate patient-facing materials (Main ICF, patient leaflet, etc.).
- Support oversight of CROs and vendors involved in monitoring and site management, ensuring day-to-day alignment with study expectations and performance standards.
- Participate in the training of the CRO Clinical Trial Lead/CRAs and sites and support the monitoring and site team to address operational challenges and maintain study momentum.
- Oversee the execution of site monitoring activities (remote and on-site), ensuring timely visit completion, issue identification, and follow-up to safeguard data integrity and patient safety.
- Perform site co-visits to ensure appropriate sponsor oversight.
- Perform any other study-level duty as required, including monitoring or co-monitoring sites as applicable.
Study Tracking & Reporting
- Coordinate and track key operational metrics (e.g., site activation, monitoring visits, enrollment, deviations) and provide regular updates to study and program leadership.
- Oversee the tracking of the study biological samples from site to central or specialized laboratories and other central study assessments, as applicable.
- Oversee IMP/study supply management in collaboration with other key study stakeholders to ensure timely delivery at country and site level and appropriate reconciliation.
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Cross Functional Coordination & External Engagement
- Partner closely with data management, safety, regulatory, supply teams, and other key study stakeholders, including CRO/Vendor teams, to ensure smooth execution of ongoing study activities.
- Perform sponsor site visits to assess study quality and performance and build strong relationships with investigators and site staff.
Issue Identification & Escalation
- Proactively identify risks and operational issues at the site or study level, driving resolution or timely escalation to the Clinical Study Manager.
Quality & Compliance Support
- Ensure adherence to GCP, protocol, and SOPs in daily execution, contributing to continuous inspection readiness through accurate documentation and follow-up.
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.
Please visit our website to find further information about our values and Orion as an employer: https://www.orionpharma.com/careers/working-with-us/
What are we looking for?
Required
- Master's Degree in life sciences or a related field.
- 5+ years of clinical operations experience, with 3+ years in monitoring oncology studies as CRA/clinical trial monitoring and/or study coordination at the site level.
- Demonstrated experience in feasibility, site selection, and site management coordination/oversight.
- Strong knowledge of ICH-GCP and global clinical trial processes, including inspection readiness.
- Team-oriented with strong collaboration skills, effective communication skills, and site engagement capabilities.
- Hands-on, pragmatic, detailed-oriented, proactive problem-solving with a solution-oriented approach and analytical skills.
- Ability to travel internationally as needed.
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Preferred
- Experience in small biotech and/or fast-paced growth environments.
How to apply
Please send your application with the latest CV and cover letter by 26th of July, 2026.
We typically review applications already during the application period and may start interviewing candidates before the application deadline. Therefore, we invite you to send your application as soon as possible.
#LI-ORION
Orion Pharma’s pharmaceutical innovations are created within its R&D organization. We employ around 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Cambridge and Nottingham in England, and in Cambridge, MA, US. 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.
Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.
We’re home to more than 4,000 Orionees around the world, and we’re 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.
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