UICEC Clinical Trial Project Manager (PM)/Monitor (CRA)

REF: 24-181_SS_PH

About the research group

Clinical Research and Clinical Trial Unit (UICEC IDIBELL) is an IDIBELL platform that gives support to the clinical research groups to conduct clinical studies without any commercial interest. UICEC activities respond to the responsibilities of researches as promoter of clinical trials (CT).
UICEC IDIBELL is part of the SCREN, a ISCIII Clinical Research Support Platform (PT23/00061)

About the role

• Project management of clinical research studies
  
  
• Elaboration of a specific plan for the clinical trial (CT) and follow up to ensure compliance with the plan.
  
  
• Ensure CT are carried out according to legal regulations, GCP and SOPs.
  
  
• Ensure CT are completed as agreed in the budget, timelines and patients inclusion commitment
• Coordination of all regulatory documents of the CT
  
  
• Supervision of monitoring activities carried out by the monitors
  
  
• Review and approve reports of visits of the centers
  
  
• Development and management of study documents and generated data (monitoring plan, CRD design and validation plan)
  
  
• Development of the communication policy with the research team of the study (organization of the initial meeting, periodic teleconferences, generation of periodic reports for the centers)
  
  
• Elaboration of studies budget and management of the billing of the tasks carried out for each study
  
  
• Monitoring of drug/devices clinical trials

Job requirements

Professional experience

• Previous 2 year experience in drug clinical trial (CT) monitoring.

Education and training

• Average degree in health sciences (Medicine, Pharmacy, Biology, Biotechnology)
  
  
• Training in clinical trials monitoring and completed practices.
  
  
• Training in monitoring and management
  
  
• Training in drug and devices clinical trials 

Technical & soft skills

• Knowledge on clinical trials ethical and legal regulation
  
  
• Knowledge on Good Clinical Practice

Languages

• Good command of the English language

We will value, but not required

• Previous experience in project management of drug CT and devices CT
  
  
• National Health System knowledge/experience
  
  
• Global professional experience and academic training
  
  
• High English level
  
  
• Communication skills and teamwork
  
  
• Motivation, initiative and learning ability

What do we offer

• No. of positions: 1
• Estimated start date: 20/01/2025
• Contract duration: Permanent
• Estimated annual gross salary: 32.000 €
• You will be part of a multicultural team. We have a fun loving and friendly international work environment.
• Flexible working schedule - We know you have a life outside of work and we will work with you to make sure it's kept that way.
• Possibility to work some days in remote -Teleworking
• 26 working days of holiday per year
• System of accumulated hours for employees, from 88 to 104 hours depending on the year (11 to 13 working days), to attend to personal matters.
• Paid leave package
• Benefits of constant training are offered
• We offer and promote diverse and inclusive conditions. Applicants are made free from any discrimination. Specifically IDIBELL works to improve gender equality in all areas with the aim of achieving gender balance, but maintaining the most scrupulous respect to any choice at the level of gender identity. Please express yourself freely, safely and non-binarily, if that's the case.

Deadline: Please submit your application by  14/01/2025

Data protection notice

In compliance with the obligations established in the General Regulation of Data Protection (RGPD), which is the Regulation (EU) 2016/679 of the Parliament and of the Council, of April 27, 2016, and the Organic Law 3/2018, of December 5, Protection of Personal Data and guarantee of digital rights, it is reported that the Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), CIF G58863317, with address Av. Granvia de l'Hospitalet, 199-203, 08908, L'Hospitalet de Llobregat, will process your personal data, as the controller, to apply for the position, maintain communication concerning the status of the candidature, to access the delivered CV; to compare that your data is in accordance with the offers announced by IDIBELL and to verify, where appropriate, that the information provided is accurate. You can find more information in our Privacy Policy at https://idibell.cat/en/privacy-policy-2/, request more information about the data processing carried out and exercise your rights of access, rectification, deletion, opposition, portability, limitation of processing by sending a request at email: dataprotection@idibell.cat. If you consider that you have not obtained satisfaction in exercising your rights, you may submit a claim to Catalan Data Protection Authority.

Our institute

IDIBELL is a research center that integrates the biomedical research of the Bellvitge University Hospital (HUB), the Catalan Institute of Oncology (ICO), and the University of Barcelona in the Bellvitge Campus (UB), and the Viladecans Hospital (HV). The research focuses of IDIBELL are cancer, neuroscience, translational medicine and regenerative medicine. Research, innovation and society are the pivots on which researchers work every day in order to improve the quality of life of citizens.

Observations:

The 'HR Excellence in Research' award represents IDIBELL’s commitment to the implementation of Human Resources policies, which oversee the attracting and development of talent in an open, transparent, and based on personal merit, in alignment with the principles of the European Charter for Researchers and the Code of Conduct for the Recruitment Researchers (Charter and Code).

IDIBELL is committed to the principles of the Code of Conduct for the Recruitment of Researchers of the European Commission and the implementation of open, transparent and merit-based recruitment (OTMR).