Oferta de trabajo: Clinical Trial Manager (maternity leave)
Descripción
The Barcelona Institute for Global Health (ISGlobal) is a cutting-edge institute addressing global public health challenges through research, translation into policy and education. ISGlobal has a broad portfolio in communicable and non-communicable diseases including environmental and climate determinants, and applies a multidisciplinary scientific approach ranging from the molecular to the population level. Research is organized in the following main areas, Malaria and other Infectious Diseases, Maternal, Child and reproductive Health, Urban Health and Child and environmental health, Climate & Non-Communicable Diseases. ISGlobal is accredited with the Severo Ochoa distinction, a seal of excellence of the Spanish Science Ministry.Lugar
Background
The project
The findings of this study will contribute to reduce SARS-CoV-2- related complications in a highly vulnerable group to the infection.
The project will be conducted in 4 sites in Spain (Madrid and Barcelona) and one site in Mozambique (Maputo)
What We Are Looking for
Main duties and responsibilities
- Trial management activities during the study period to close out
- Management of clinical trial monitors
- Review and approval of monitoring reports
- Review and approval of monitor timesheets and expenses
- Site management and closure
- Trial tracking
- Verify that all subject research activities undertaken in project hospitals are conducted according to the standards of ICH-Good Clinical Practice, international and local regulations.
- Receives and takes appropriate action following monitoring reports
- Oversees and coordinates study drug supply from procurement to delivery on site, including the required documentation
- Maintains responsibility for the Trial Master File and archiving of thereof, for the correct filing and archiving of clinical trial documents, and the maintenance of study files.
- Coordinates, manages and participates in clinical trial meetings
- Provides project status updates and reports to the PI as required
- Risk identification and escalation to the PI
- Issue identification and applicable escalation to the PI
- Assists with HSR training of field staff.
- Attends consortium and other meetings as required. Presents data as required.
- Contributes to funder reports
Qualifications
- Excellent communications and collaboration skills.
Required
- At least 1 years of experience across all stages of the clinical trial lifecycle, i.e. from protocol development to final study report, and especially in managing clinical trials.
- Minimum of BSc or health/science degree equivalent
- Current ICH/GCP certification
- Excellent written and spoken Spanish and English
- Willingness to travel to the project hospitals in Spain (Madrid and Barcelona)
Preferred
- Working experience in Portuguese
How to Apply:
Applicants must fill in the request form and include the following code reference position: CTM_SARA_May23, attach the CV and a Cover Letter. Each attached document must be named with the candidate name and surname.
The receipt of applications will be open until 31 May 2023.
Applications will be accepted until 17.00 CET of the closing date.
Only the applications submitted through the request form will be considered.
Only shortlisted candidates will be contacted.
The interviews could be placed during the reception candidatures period.
Diverse candidacies, gender, race, ethnicity, religion, age, sexual orientation, physical abilities, and political views, are encouraged to apply.
In ISGlobal we are committed to maintaining and developing a work environment in which the values and principles of our organization are respected and equal opportunities between women and men be promoted in each of the areas in which we operate, not tolerating discrimination based on criteria such as age, gender, marital status, race, ethnicity, functional diversity, political leanings, religion, sexual orientation, gender identity or gender expression.
ISGlobal supports the initiative #ScienceforUkraine. Therefore, to sustain Ukraine’s presence in the European Research Area and international scholarly community, candidates from Ukraine on all levels of scholarly career are welcome: students, PhD candidates, early career researchers and senior scholars.
We confirm our commitment towards the value of the diversity of our staff and student population and seek to promote peace, equity, diversity and inclusion as essential elements in contribution to improving health worldwide.