Trial Lead
Hr On Demand Sweden AB / Biomedicinjobb / Göteborg
2025-11-11
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hela Sverige At Ribocure, we are driven by science and innovation, with a mission to establish a world-leading company in RNA research and development, ultimately making a positive impact on patients worldwide. We are seeking a Trial Lead (clinical study manager) to join our growing Clinical Operations team and take a leadership role in driving the successful execution of our clinical trials.
In this role, you will lead the operational execution of one or more clinical trials across all phases of development. You will be accountable for ensuring delivery of high-quality, compliant, and cost-effective clinical trials within agreed timelines and budgets. You will manage cross-functional collaboration within the trial team, coordinate with internal stakeholders and external service providers, and oversee all aspects of clinical trial operations, from planning through reporting and close-out.
We are looking for a candidate with experience in clinical trial leadership in the pharmaceutical or biotech industry, strong organizational and communication skills, and the ability to combine sponsor oversight with hands-on execution in a dynamic, fast-paced environment.
Key responsibilities:
Lead the Clinical Trial Team to ensure efficient planning, start-up, execution, reporting, and close-out of assigned clinical trials in compliance with ICH-GCP, regulatory requirements, and company SOPs.
Act as the operational lead and primary point of contact for all trial-related activities, ensuring delivery within scope, quality, budget, and timelines.
Provide clear leadershipand direction to the cross-functional trial team (including Medical, Data Management, Biostatistics, Pharmacovigilance, Supply Chain etc) to ensure operational alignment and proactive risk management.
Develop and maintain key trial documents such as the Clinical Trial Protocol, operational plans, and study manuals; contribute to clinical sections of regulatory submissions and trial applications.
Oversee external partners, including CROs and service providers: responsible for service provider identification, contracting, budget management, day-to-day oversight, and performance tracking to ensure quality and compliance.
Establish and maintain effective relationships with investigators, clinical sites, and CROs to support optimal site engagement, recruitment performance, and issue resolution.
Ensure efficient site management, including site selection, initiation, training, monitoring performance, and supporting timely data entry, query resolution, and deliverables.
Participate in the setup and management of clinical systems (e.g., EDC, IRT, eTMF) by contributing to CRF design, user acceptance testing, and development of completion guidelines.
Monitor trial metrics and data quality to ensure timely and accurate trial information in all tracking systems and databases.
Coordinate clinical supply planning and QP release activities in collaboration with supply chain functions.
Ensure implementation of trial-level risk management activities and proactively identify, mitigate, and communicate potential issues or deviations.
Contribute to the continuous improvement of Ribocure's Clinical Operations processes, tools, and quality systems.
Requirements:
University degree, preferably in medical or biological science or discipline associated with clinical research
At least 5 years' experience from within the pharmaceutical industry and proven experience of clinical development / drug development process in various phases of development and therapy areas
Comprehensive knowledge of the clinical and pharmaceutical drug development process
Excellent knowledge of ICH-GCP principles
Strong organizational skills and ability to manage multiple priorities
Excellent communication and organizational skills
Desired requirements:
Experience in managing early clinical trials
Project management certification
Why Join Us?
We offer more than a job - we offer a mission. You'll be part of a tight-knit, friendly team working on real challenges with real potential. Your ideas matter. Your work matters. And your growth matters to us.
Ready to Apply?We encourage you to submit your CV and cover letter promptly, as applications will be reviewed on an ongoing basis. Final application deadline: 14th of December.
Hiring manager: Rebeckha Magnusson, Head of Clinical Operations & QA
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2026-04-30
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Hr On Demand Sweden AB (org.nr 556743-5036)
Arbetsplats HR On Demand
Kontakt Rebeckha Magnusson
rebeckha.magnusson@ribocure.com +46 (0)73 635 88 49 Jobbnummer 9600042