Clinical Trial Assistant

il y a 1 semaine


Gent, Flandre, Belgique Proclinical Temps plein

Proclinical are partnering with a small Contract Research Organisation (CRO) that provides high-quality clinical research services to the pharmaceutical, biotech, and medical device industries.

They are an exciting CRO who are developing in size and are working with exciting companies.
They are currently seeking a highly motivated Clinical Trial Assistant to join their team in Ghent.

Summary:

Responsibilities:

  • Assist with the preparation and submission of regulatory documents, including informed consent forms, study protocols, and clinical study reports.
  • Assist with the tracking and management of study materials, including investigational products and clinical trial supplies.
  • Collect and manage study data in accordance with the study protocol and regulatory requirements.
  • Assist with the preparation and maintenance of studyrelated documents, including study files, study plans, and meeting minutes.
  • Prepare and distribute studyrelated materials to study team members, including investigators and study coordinators.
  • Support study closeout activities, including the finalisation of study reports and archiving of study documents
  • Ensure compliance with all applicable regulations and guidelines, including ICH-GCP, local regulatory requirements, and company SOPs.
  • Ensure that all study team members are trained on the study protocol, study procedures, and other studyspecific requirements.
  • Communicate study progress, issues, and risks to internal and external stakeholders, including sponsors, investigators, and study teams.

Requirements:

  • Bachelor's degree in a relevant field (life sciences, healthcare, or related field).
  • At least 2 years of experience as a Clinical Trial Assistant (CTA) in a clinical research setting.
  • Strong knowledge of ICH-GCP and regulatory requirements.
  • Excellent organisational and communication skills.
  • Ability to manage multiple priorities and meet deadlines.
  • Strong interpersonal skills and ability to work effectively in a team environment.
  • Fluent in English with Dutch and French being strong assets.


They offer a competitive salary and benefits package, a dynamic and friendly work environment, and opportunities for career growth and development.

This position will be based in Ghent with the opportunity for hybrid working.


Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-AA2

Clinical
  • Clinical Trial Manager

    il y a 1 semaine


    Gent, Flandre, Belgique Argenx Temps plein

    As we are growing, we are currently looking for a Clinical Trial Manager (CTM).The CTM is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II and III drug development phases and is an operational...


  • Gent, Flandre, Belgique MindCapture Temps plein

    CLINICAL TRIAL SUPPLY MANAGER Biopharma Ghent & remoteWHAT IS OFFEREDWe offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance....


  • Gent, Flandre, Belgique Proclinical Temps plein

    Proclinical is seeking dedicated Clinical Project Managers to join a dynamic team in Belgium. This role is perfect for those who are passionate about managing clinical trials and have a keen interest in complex therapy areas. This is a global role, offering the opportunity to work on projects from Phase I to III. This role holds a hybrid working model with 2...


  • Gent, Flandre, Belgique Proclinical Temps plein

    Proclinical is seeking dedicated Clinical Project Managers to join a dynamic team in Belgium. This role is perfect for those who are passionate about managing clinical trials and have a keen interest in complex therapy areas. This is a global role, offering the opportunity to work on projects from Phase I to III. This role holds a hybrid working model with 2...

  • Clinical Trial Manager

    il y a 1 semaine


    Gent, Flandre, Belgique Meet Recruitment Temps plein

    Clinical Trial Manager - Belgium - Pharma Leading global crossfunctional project team delivery, accountable for achievement of milestones and quality of contracted scope Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures Anticipating risk and...


  • Gent, Flandre, Belgique Argenx Temps plein

    We are currenty looking for a Clinical Operations Development Lead (CODL) to strengthen the Global Clinical Trial Operations team. The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (Xindication CODL)....


  • Gent, Flandre, Belgique Argenx Temps plein

    Due to the exponential growth of argenx worldwide, we are currently looking for several _Clinical Operations Development Leads (CODL) _to strengthen the Global Clinical Trial Operations team. Ideally, location would be based in Belgium._ The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a...


  • Gent, Flandre, Belgique MindCapture Temps plein

    FRANCHISE CLINICAL OPERATIONS DEVELOPMENT LEAD Biotech GhentWHAT IS OFFEREDFranchise Clinical Operations Development Lead plays a critical role in overseeing the operational path for all indications within a franchise. Functioning as a line manager, and ensuring consistency to synergy across different indication teams. The Franchise Clinical Operations...


  • Gent, Flandre, Belgique Argenx Temps plein

    The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (X-indication CODL). Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical...


  • Gent, Flandre, Belgique MindCapture Temps plein

    CLINICAL OPERATIONS DEVELOPMENT LEAD Biotech Ghent & remoteWHAT IS OFFEREDThe Clinical Operations Development Lead plays a critical role in ensuring the success of clinical trials and the development of new therapeutic assets, coordinating efforts across various functions and stakeholders to drive effective clinical development strategies.Next to a...


  • Gent, Flandre, Belgique Argenx Temps plein

    To strengthen our Global Clinical Trial Operations team, we are currently looking for a Franchise Clinical Operations Development Lead (Franchise CODL).The Franchise CODL is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through authorization and...


  • Gent, Flandre, Belgique Argenx Temps plein

    This position reports into the Head Clinical Operations Excellence. We want to fill in the position in Europe or the United States.Roles & Responsibilities Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents. Identify and drive continuous...


  • Gent, Flandre, Belgique Argenx Temps plein

    For the expansion of our Regulatory team, argenx is looking for a Center of Excellence Regulatory Lead who is responsible for: managing the team of regulatory associates that performs regulatory oversight for the individual studies.Key Accountabilities/Responsibilities: Maintain an indepth knowledge of the fastevolving global clinical trial regulations...

  • Clinical Research Associate

    il y a 1 semaine


    Gent, Flandre, Belgique Proclinical Temps plein

    Proclinical are recruiting a Clinical Research Associate for a CRO. This role is on a permanent basis with the ability to work remotely from anywhere in Belgium. The client is focused on preserving harmony in the performance of clinical trials.Responsibilities: Conduct source data verification in compliance with the needs as set out in the monitoring manual....

  • Franchise Codl

    il y a 1 semaine


    Gent, Flandre, Belgique Argenx Temps plein

    Franchise Clinical Operations Development Lead ( Franchise CODL)PURPOSE OF THE FUNCTIONThe Franchise CODL is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through authorization and commercialization. The franchise may involve several assets and/or...

  • Franchise CODL

    il y a 1 semaine


    Gent, Flandre, Belgique Argenx Temps plein

    Franchise Clinical Operations Development Lead ( Franchise CODL)PURPOSE OF THE FUNCTIONThe Franchise CODL is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through authorization and commercialization. The franchise may involve several assets and/or...


  • Gent, Flandre, Belgique Meet Recruitment Temps plein

    110000 EUR EUR Ghent, Belgium PermanentAbout:Our client is a leading, innovative biotechnology company dedicated to developing cutting-edge antibody products to transform patients' with autoimmune disease lives. They are at the forefront of the immunology space, pioneering groundbreaking treatments for various diseases. Their mission is to revolutionize...


  • Gent, Flandre, Belgique Universiteit Gent Temps plein

    Faculty of Engineering and Architecture:- Department: EA0 Informatietechnologie:- Occupancy rate:50%:- Number of positions: 1:- Type of employment: Contract of limited duration:Term of assignment: tot :- Wage scale: PD1 to PD4 (doctoral degree):- Required diploma: PhDABOUT GHENT UNIVERSITYGhent University (BE) is a world of its own. Employing more than...

  • Site Administrator

    il y a 1 semaine


    Gent, Flandre, Belgique Viroclinics Biosciences Temps plein

    As Site Administrator you are responsible for the day-to-day operational tasks to support the Project Management team with Clinical Trials. The Site Administrator is part of site response team.Your responsibilities will be:Manual results entry into the Clinical Trial Management system (CTMS); Follow internal procedures to complete manual results entry into...

  • Biostatistics Lead

    il y a 1 semaine


    Gent, Flandre, Belgique Argenx Temps plein

    We are looking for a lead biostatistician, to join the team of biostatistics as part of Quantitative Sciences. The position will be located in any of our affiliations in Ghent (Belgium) or Boston (US).Your role: You are a statistical leader in the crossfunctional development team of one compound/indication You contribute with statistical expertise to the...