Senior Clinical Research Associate

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Clinical

Niveau de Séniorité: Specialist

Medha Khanna

Senior Talent Acquisition Manager

Conditions pour les agences de placement

Votre profil

Vifor Pharma a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, we are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. Due to expansion we are looking at this time to appoint a Senior Clinical Research Associate based in Switzerland to operate across Europe at sites for a development product within the field of rare CKD providing vendor oversight, report and study plan reviews and following up on CRO open actions.

You have on-site monitoring experience and looking to take the next step working with a talented team to bring important medicines to market for the patients we serve. Reporting to the Director, Clinical Operations, you will support the management of clinical trials sponsored by the company, including management of contract service providers (CROs and vendors). 

Activities

  • Conduct oversight visits (e.g., accompany site selection visits, training visits, site initiation visits, interim monitoring visits, and close-out visits) and plan and conduct motivational site visits (Sponsor visits)
  • Support patient recruitment by close collaboration with the study sites, the CRO and internal stakeholders
  • Track and follow-up on status of clinical trial deliverables
  • Provide project-specific support for external study team ( site staff as well as personnel at CRO and other clinical study vendors) and ensure proper adherence to clinical research regulations
  • Participate in project team meetings and collaborate with other functional groups within the company (Clinical Development, Drug Safety and Pharmacovigilance, Biometrics, Clinical Research Compliance, Regulatory, QA, Pharmaceutical Operations, Legal, Medical Affairs, etc.) to achieve clinical study goals and timelines
  • Support the internal study teams if needed (e.g. organize meetings, develop meeting agendas, take meeting minutes)
  • Participate in development of project-specific documents (e.g. ICF, protocol, eCRF etc.),  study plans and other study-related documents (manuals, instructions, etc.)
  • Support site selection process for clinical trials
  • Manage external vendors and their systems (e.g., CTMS, EDC, IWRS, eTMF, etc.)
  • Coordinate and participate in Investigators’ Meetings
  • Identify training needs and support training of CRO CRAs
  • Review and follow-up on monitoring visit reports ensuring adherence to GCP/ICH
  • Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on clinical studies
  • Coordinate the collection and management of clinical trial documentation to be filed in Trial Master File and Electronic Study Files

Requirements

  • Bachelor’s degree in science, nursing, or equivalent with 4+ years of experience in biotech, pharmaceutical, or CRO industry, advanced degree (PhD, MD, PharmD) is a plus
  • Substantial experience in on-site monitoring and interaction with investigators is a must
  • Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials 
  • Ideally experienced in oversight of contract service providers
  • Proficiency in Microsoft Word, Excel, PowerPoint
  • Experience with different EDC and IWRS platforms
  • Willingness to travel frequently (international, mainly Europe) including overnight stays

A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter www.viforpharma.com/career

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