Clinical Operations Manager

il y a 1 semaine


MontSaintGuibert, Wallonie, Belgique Novadip Biosciences Temps plein

Responsibilities:

  • Organization and management of clinical operations activities, adhering to standards and regulations required within the field: notably ICH guidelines (including GCP) and all other EU/US legislation and directives relating to clinical research activities.
  • Development, management and evaluation of all aspects about "Clinical Compliance" in partnership with the Clinical Quality representative
  • In partnership with the Clinical Director and Clinical Science Manager:
  • Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, INDs, IMPDs, study synopses and protocols, clinical study reports, DSURS and other safety reports.
  • Provide input into clinical trial timeless of the clinical development plan.
  • Execute clinical trials from protocol design to the final clinical study report.
  • Streamline financial management to ensure proper forecasting, budgeting and oversight for the implementation of the clinical development plan.
  • Provide expert clinical operations input into preparation for essential regulatory meetings (e.g., Pre-IND, EndofPhase 2, Scientific Advice Meetings)
  • Line management of the clinical operations team
  • Provide as needed handson support to the clinical operations team in the:
  • Preparation and/or management of all documentation relating to a clinical trial (e.g., study protocol, patient informed consent, CRF, trial management plan, risk management plan, safety plan)
  • Selection and management of CRO and other subcontractors involved in the clinical trials.
  • Management of interactions with ethics committees and competent authorities
  • Monitoring and coordination of patient recruitment plans
  • Coordination of exchanges with investigators and management of site visits
  • Training/ coaching operational teams involved in clinical trials (interna and external)
  • Conduct of onsite monitoring, trial logistics, and establishing permanent contact with named investigators.

Profile:

  • Scientific educational background: Master or PhD.
  • Minimum 10 years of experience in clinical research experience with a pharmaceutical company or CRO (preferably including people management) with a handsonmentality.
  • Management experience with multicenter studies including global clinical trials (US study conduct is an asset).
  • Strong understanding of the principles of clinical trial conduct and project management.
  • Solid experience in CRO management.
  • Strong regulatory knowledge, including Good Clinical Practices (GCPs).
  • Experience with protocol, ICF, CRF and CSR development and review.
  • Strong organizational skills and ability to deal with competing priorities.
  • Excellent leadership skills.
  • Solid computer skills with a working knowledge of Windows and Microsoft Office.
  • Good oral and written communication skills, be able to communicate effectively in English.

Offer:

  • A fulltime permanent position (40h/week) within a highpotential innovative biotech company.
  • To work in a humansized, dynamic, respectful, and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • An attractive salary package in line with the position responsibilities and your experience.

  • Clinical Trial Assistant

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Novadip Biosciences Temps plein

    Your responsibilities: Primary Role_Trial Master File management and administrative support, in compliance with SOPs, ICH guidelines (including GCP) and all other EU/US legislations and directives relating to clinical research activities. Nature and scope of responsibilities_Trial Master File (TMF) management from study start-up to close-out, ensuring all...


  • Mont-Saint-Guibert, Wallonie, Belgique Lilly Temps plein

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Mont-Saint-Guibert, Wallonie, Belgique Unique Temps plein

    Description:ROLE Support the compilation and verification of documentation provided relating to the requirements of MHRA guidance for the importing of IMPs into Great Britain from approved countries. Verification will involve the review of documentation provided by the clinical trial study sponsor and /or external contract giver, as applicable, to verify a...

  • Marketing Manager

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Clinigen Temps plein

    We're looking for a Marketing Manager based in Belgium to work on a remote hybrid basis. This position is responsible for designing and implementing marketing and communication initiatives to support the Clinical Services business, as well as other business units and Group-wide projects, as needed. Acting as a Marketing Business Partner, the role aims to...


  • Mont-Saint-Guibert, Wallonie, Belgique Guided Solutions Temps plein

    Our client is a fast-growing medical technology company focused on the development and commercialization of innovative solutions and services for the treatment of Obstructive Sleep Apnea (OSA). With this method, patients who are not allowed to undergo conventional treatment receive a significant reduction in apnea and hypopnea events.As part of their...

  • Quality Assurance Assistant

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Novadip Biosciences Temps plein

    Your responsibilities: Assist with the management (check, approval, distribution) of specifications, work instructions and other Novadip quality system documents In collaboration with QC and the QP, assist with the management of the storage facilities for raw materials, intermediates, finished products and packaging materials Manage the release of Novadip...


  • Mont-Saint-Guibert, Wallonie, Belgique Unique Mt Saint Guibert Temps plein

    Our client is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. It aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the...

  • Marketing Manager

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Abbott Laboratories Temps plein

    The opportunity:Abbott Medical Devices are recruiting Medical Managers to be based in the EMEA HQ in Diegem, Belgium.Please note this is a pipeline for future roles within the organizationRole and Responsibilities: Develop an annual marketing strategy and plan (product management and marketing activities) for and with Countries/Regions commercial...

  • Lab Manager

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique PlusOne Temps plein

    _-__Mont-Saint-Guibert__- _About our clientOur client, Vesale Bioscience, is a company dedicated to organizing the development, production and distribution of bacteriophages. Modern phage therapy is the most promising treatment against antibiotic multiresistant bacterial (AMR) infections, one of the biggest global health challenges, referred to as "the next...

  • Project Manager

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Syngenia Temps plein

    We are looking for a Project Manager for our client in Brabant Wallon.Mission Is responsible for the financial result of the EPC, EPCM or basic engineering project. Defines the profile of the members of the project team that he needs to assure the success of the project (Project Engineers, Project Assistant ). Establishes and monitor the overall planning of...

  • Bsm Manager

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Unique Temps plein

    Description:ROLE Guarantee that the services delivered by the Biosamples management unit always meet the defined specifications (quality, regulatory requirements, deadline and other KPI). Be an expert in the field of activity and propose technical solutions and improvements. Know the specifications of each study and accordingly inform/train the operators...

  • Quality Manager

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique 2BeGood Temps plein

    The objective of the role as Quality Manager is to implement an optimal quality management system within the company. You will be responsible for ensuring that this system is understood, implemented and maintained at all levels of the organization to meet customer demands, various international standards and business requirements.As an experienced Quality...

  • Accounting Manager

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Robert Half Belgium Temps plein

    Robert Half is looking for an Accounting Manager (M/F/X) for one of their clients located in Mont-Saint-Guibert.Robert Half is looking for an Accounting Manager (M/F/X) for one of their clients located in Mont-Saint-Guibert.Our client is an international and publicly traded company in Life Sciences sector, we are seeking a highly skilled and experienced...

  • Office Assistant

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Daoust Temps plein

    Travailler vous rend fier ? Alors, Daoust est l'entreprise idéale pour vous ! Avec une solide expérience depuis 1954, des valeurs affirmées et certifiée Top Employer chaque année depuis 2020, Daoust est le partenaire parfait pour vous aider à trouver le job de vos rêves. Nous vous accompagnons à chaque étape de votre vie professionnelle grâce à...


  • Mont-Saint-Guibert, Wallonie, Belgique De Smet Engineers & Contractors Temps plein

    MissionDevelops sales and DSEC's presence in the market for DSEC's activities in a specific market or for a specific product.Participates to and initiates commercial actions.He reports to the Chief Sales Officer.Main tasks and responsibilities: Participate in the development of a business strategy Identify the challenges and issues relating to projects...

  • Office Assistant

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Daoust Temps plein

    Pour l'un de nos clients, un cabinet d'avocats, nous sommes à la recherche d'un profil administratif pour l'Office Management à mi-temps (19h par semaine - 2,3 jours).Le cabinet a une clientèle nationale et internationale et opère dans divers domaines du droit des affaires.Responsabilités : Accueil et réception : Gestion des appels téléphoniques et...


  • Mont-Saint-Guibert, Wallonie, Belgique Lhoist Temps plein

    Looking for a place where you can make a difference? Develop your talents in our challenging and rewarding environment. To strengthen our Procurement team based in Corbais, Belgium, we are looking for a talented individual to fill the position of End-to-End Procurement Process Specialist. About the role As a End-to-End Procurement Process...


  • Saint-Ghislain, Wallonie, Belgique Google Temps plein

    Minimum qualifications: Bachelor's degree in Computer Science, a related technical field, or equivalent practical experience.Preferred qualifications: Experience working in data center environments, including building and operating largescale infrastructure, and network and compute architecture and lifecycle, and Linux/Unix system administration. Experience...

  • de Production

    il y a 1 semaine


    Mont-Saint-Guibert, Wallonie, Belgique Heidelberg Materials Benelux Temps plein

    Nous recherchons des personnes talentueuses comme vous pour nous rejoindre Grâce à vos compétences et à votre passion, nous disposerons des ressources nécessaires pour concrétiser notre vision et nous engager en faveur du développement durable. C'est notre priorité absolue Nous considérons la lutte contre le changement climatique comme essentielle...


  • Saint-Ghislain, Wallonie, Belgique Google Temps plein

    Minimum qualifications: Bachelor's degree or equivalent practical experience. Experience in Critical Facility Operation Management. Ability to speak and write in English fluently.Preferred qualifications: Experience working in data center environments (e.g., building and operating infrastructure). Experience with managing and executing initiatives in a...