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Magyarország
Hybrid
Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.
We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.
If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you!
The Senior Clinical Research Associate (Sr. CRA) independently performs, coordinates and oversees clinical site monitoring activities, ensuring compliance with study protocols, Alimentiv and sponsor procedures, ICH-GCP guidelines and local regulatory requirements.
Serving as a primary liaison between investigative sites, Alimentiv and sponsors, the Sr. CRA plays a key role in the successful execution of clinical studies from site selection and start-up through monitoring and close-out. This role also provides guidance and mentorship to CRA I and CRA II colleagues and may participate in CRA assessment visits, co-monitoring activities, audits and inspections.
Independently conduct and document onsite and remote site management activities, including site qualification, initiation, monitoring and close-out visits, in accordance with applicable SOPs and study requirements.
Serve as a primary point of contact for investigative sites, building effective working relationships and ensuring site questions, issues, action items and protocol deviations are followed through to resolution.
Review source documentation and study systems to ensure clinical data is accurate, complete and compliant with protocol, regulatory and study requirements; manage and facilitate the resolution of data queries.
Oversee site activation and ongoing site management activities, working with sites and cross-functional teams to achieve project timelines, milestones and recruitment objectives.
Ensure site personnel are appropriately trained on study protocols, plans, systems, ICH-GCP requirements and project-specific expectations.
Routinely review Investigator Site Files (ISF), Trial Master Files (TMF) and study systems for accuracy, completeness, timeliness and compliance, requesting outstanding documentation as required.
Coordinate site-related study activities and communications, including clinical supplies, investigational product, laboratory materials, ePROs, study documentation and ongoing project updates.
Collaborate with Study Start-up, Regulatory and other cross-functional teams, including supporting document collection, localisation and translation activities where required.
Participate in study meetings, Investigator Meetings, audits and inspections, supporting issue resolution and implementation of corrective actions when required.
Mentor and support CRA I and CRA II colleagues, including CRA Assessment Visits, co-monitoring and sign-off activities; contribute to CRA interviews, training and process improvement initiatives as requested.
(Honours) Bachelor’s degree required; a degree in Health Sciences, Life Sciences, Pharmacy or Nursing is preferred. A Master’s degree is considered an asset.
Minimum 4–6 years of relevant clinical research experience; 7–9 years of related experience is preferred.
Experience across Phase I–IV clinical trials is preferred.
Thorough knowledge of ICH-GCP and applicable local regulatory requirements.
Demonstrated experience independently conducting site qualification, initiation, monitoring and close-out visits.
Proficiency with clinical trial systems including EDC platforms (e.g., Medidata Rave, Oracle InForm), IRT, eTMF and CTMS, as well as Microsoft Office.
Strong interpersonal, communication and problem-solving skills, with the ability to work independently and effectively within cross-functional teams.
Strong organisational skills, attention to detail and the ability to manage priorities with an appropriate sense of urgency.
Fluent written and verbal English; an equivalent combination of education and relevant experience may be considered.
Valid driver’s licence and ability to travel approximately 40–60%, depending on project assignment and the geographic location of investigative sites.
In addition, as an Alimentiv Employee, you’re also eligible for the following programs:
Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.
To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn’s Easy Apply. Resumes must be submitted in English.
Alimentiv is aware of a continued increase in phishing scams, which use various methods of attack via email, text, voice and social media, including individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process.
Official communication will only come from company email addresses containing "@alimentiv.com". If you are contacted about an open job at Alimentiv, please verify the domain of the sender's email address and confirm that you are being asked to apply on this website. If something doesn't feel right, we encourage you to verify before responding. If you believe you have been the victim of a phishing scam, please contact your local government cyber authority to report it.
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