Clinical Study Specialist I

CellCarta; Antwerpen; Hybride; EUR 52 000 - 70 000; Plein temps

Résumé du poste

CellCarta in Belgium is seeking a Clinical Study Specialist I to ensure site-level regulatory documentation, monitoring visits, and action item follow-up are conducted with precision. You will act as a liaison between Project Management, Regulatory Affairs, and QA to sustain audit readiness across oncology trials.

You will manage essential documents (FDFs, CVs, MLs), oversee site initiation activities, and support SIVs, monitoring prep, and close-out processes, contributing to compliant trial

Qualifications

• 2+ years in clinical research (CRO or pharma).
• GCLP and GDP knowledge required.
• Oncology protocols and high-volume documentation familiarity.
• Experience with eTMF (Veeva Vault) and CTMS.
• Fluent in English.
• Strong organizational skills and proactive problem-solving.

Responsabilités

• Monitoring oversight & Action Item management: review and drive AIs to resolution with monitors/site staff.
• Site startup & activation: collect and file essential documents for SIVs and site activation.
• Close-out visit & study deactivation: oversee logistics and reconcile documents for site closure.
• RA & QA collaboration: prepare packages for regulatory submissions, track amendments, gaps in eTMFs.
• System & logistics facilitation: manage site access to EDC, IRT, and eTMF; organize docs for SIVs.
• Cross-trial process optimization: maintain dashboards for PMs showing open action items and compliance metrics.

Connaissances

GCLP/GDP

eTMF systems

English proficiency

Clinical research experience

Formation

Bachelor’s or Master’s in Life Sciences/Pharmacy

Outils

Veeva Vault

Description du poste

Clinical Study Specialist I

Are you a clinical operations professional who thrives on precision, compliance, and process efficiency? We are looking for an energetic Clinical Study Specialist I to join our growing Clinical Operations team and support the successful execution of innovative oncology clinical trials.

Summary

In this role, you will be responsible for the operational success and integrity of site-level regulatory documentation, clinical monitoring visits, site initiation visits, close-out visits, and related action item follow-up. Acting as a central liaison between Project Management, Regulatory Affairs (RA), and Quality Assurance (QA), you will ensure that all site initiation activities (SIVs), monitoring preparation, conduct, and follow-up activities, as well as essential document collection (FDFs, CVs, and MLs), are executed with precision. You will own the action item lifecycle, driving compliance and monitoring readiness across a diverse portfolio of complex oncology trials.

Responsibilities

• Monitoring Oversight & Action Item Management: Review third-party monitoring visit reports, log Action Items (AIs), and actively drive them to resolution by following up directly with monitors and site staff
• Site Startup & Activation ("Green Light"): Manage the collection, quality control, and filing of site-level essential documents (Financial Disclosure Forms, updated CVs, medical licenses, and laboratory certifications) required for Site Initiation Visits (SIVs) and site activation
• Close-Out Visit & Study Deactivation: Oversee close-out logistics and documentation, ensuring complete reconciliation of all documents and resolution of all outstanding queries prior to formal site closure
• RA & QA Collaboration: Prepare document packages for Regulatory Affairs (for EC and IRB submissions), track protocol amendments and ICFs, and conduct periodic gap analyses of eTMFs to maintain a constant state of audit readiness
• System & Logistics Facilitation: Manage site and monitor access to critical trial systems (EDC, IRT, and eTMF) and assist in organizing documentation for SIVs and investigator meetings
• Cross-Trial Process Optimization: Maintain central monitoring dashboards to provide Project Managers with real-time visibility into open action items and study compliance metrics

Education

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field

Main Requirements

• 2+ years of hands‑on experience in clinical research (CRO or pharma). Experience as a Field CRA, In‑house CRA, or Study Startup Specialist is strongly preferred
• Understanding of Good Clinical Laboratory Practice (GCLP) and Good Documentation Practices (GDP) is required
• Familiarity with oncology protocols and their associated high‑volume documentation (frequent amendments, complex lab kits, and staff logs)
• Experience navigating eTMF systems (e.g., Veeva Vault) and CTMS platforms
• Professional fluency in English is mandatory
• Strong organizational skills, keen attention to detail, and a proactive, solution‑oriented approach

Working Conditions

• Full‑time position requiring 100% onsite attendance

About CellCarta

CellCartais a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late‑stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.

Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!

Join us as we make an impact on patient therapy!

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, "CellCarta"). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.

CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact [e-mail].