Clinical Site Associate Oncohematology

hace 1 semana

Madrid, Madrid, España Novartis A tiempo completo
766 million patients were reached with Novartis medicines.

We aspire to get Novartis medicines in the hands and homes of patients by delivering a Triple Win:
A Win for Patients; A Win for Healthcare Systems, and A Win for Novartis.

  • The Clinical Site Associate performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Hematology clinical trials within the country. The Clinical Site Associate is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
    Your responsibilities include, but are not limited to:
  • Trial Monitoring strategy
  • Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials Allocation, initiation and conduct of trials
  • Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
  • Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
  • Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
  • Facilitates the preparation and collection of site and country level documents
  • Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
  • Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
  • Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
  • Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
  • Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
  • Attends onboarding, disease indication and project specific training and general CRA training as required
  • Documents monitoring activities appropriately following Novartis standards
  • Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed
  • Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
  • Performs additional task as assigned Delivery of quality data and compliance to quality standards
  • Monitors studies as per current legislations, ICH/GCP and Novartis standards Version complete in word document
  • Involved in Site Excellence initiative and Cross-Functional activities, as Site Ambassador, with a holistic view of the sites, promoting the direct contact due to a regionalized model.
  • Is the frontline liaison to ensure successful collaboration and to facilitate communication between sites and Novartis CPO.
  • Ensures to increase the engagement with sites and leverage interaction level with other stakeholders, such as medical department, MSL or Market Access.

Commitment to Diversity & Inclusion:

  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

What you'll bring to the role:

  • Education: Degree in scientific or healthcare discipline.
  • Languages: Fluent in both written and spoken English and Spanish, as needed in clusters/countries
  • Experience:
  • Minimum of 3 years experience in site monitoring
  • Excellent knowledge of the drug development process
specifically clinical trial/research- Knowledge of international standards (GCP/ICH, FDA, EMEA)

  • Ability to manage multiple priorities and manage time efficiently.
  • Basic project management skills to support in
CSM activities.- Ability to travel domestically (and possibly internationally) as needed to study sites and

for training and meetings.- A minimum of 50% overnight travel may be required.

  • Advanced communication skills, ability to influence others.
  • Good strategic thinking: Ability to anticipate potential
issues and take appropriate actions with or without supervision

  • Advanced data accuracy:
Ability to work focused with a great attention to detail.

  • Ability to manage sites independently; Proven ability to work independently with or without mínimal supervision by direct.

You'll receive:
Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexib

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