Clinical Trial Manager

**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**:

- Barcelona**Background**:

- SARS-CoV-2 infection in pregnancy is associated with poor maternal and perinatal outcomes. One explanation is the pregnancy-associated prothrombotic status, which may increase during infection, leading to placental and vascular complications. Administration of low-dose acetylsalicylic acid (LDASA) has been shown to improve maternal and perinatal outcomes in women at high-risk of endothelial and placental complications. However, there are no data on the effects of LDASA in preventing complications in SARS-CoV-2- infected pregnant women.**The project**:

- SARA is a La Marató funded, 2-year project, a randomized, double-blinded, placebo-controlled multicentre trial in 398 SARS-CoV-2-infected pregnant women with the objective of evaluating the efficacy and safety in reducing the incidence of adverse maternal and perinatal outcomes of adding daily LDASA to the already recommended low molecular weight heparin (LMWH) from the first or second trimester up to 36 weeks’ gestation in SARS-CoV-2-infected pregnant women. Pregnant women undergoing routine first or second trimester blood tests will have a SARS-CoV-2 rapid antigen test done if they agree to participate. In case of being positive for the SARS-CoV-2, she will be randomised 1:1 to receive, additionally to LMWH for at least 10 days, daily LDASA (150 mg) or placebo, up to 36 weeks of pregnancy. Women will be followed-up for the duration of the intervention and the pregnancy outcome will be registered.
- 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**:

- The CTM will work closely with the Research Assistant and the Financial Manager who are responsible for the overall project tracking, and budgets/accounting, respectively.**Main duties and responsibilities**:
- Support the clinical research team at the coordination office and project hospitals in the full spectrum of the trial including:
- 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
- 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**:
**Applications will be accepted until 17.00 CET of the closing date.**

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 exp