Spain

Clinical Trial Manager for the GRACE study

Organization
Posted
Closing date

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, and applies a multidisciplinary scientific approach ranging from the molecular to the population level. Research is organized in three main areas, Malaria and other Infectious Diseases, Child and Maternal Health, and Urban Health, Climate & Non-Communicable Diseases. ISGlobal is accredited with the Severo Ochoa distinction, a seal of excellence of the Spanish Science Ministry.

Location:

Barcelona

What We Are Looking for

ISGlobal is seeking an experienced Clinical Trial Manager who is interested in taking over and managing activities of the clinical trial “A Phase III, randomized, double-blind, placebo-controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted respiratory syncytial virus (RSV) Maternal vaccine, administered IM to pregnant women 18 to 49 years of age, for prevention of RSV associated lower respiratory tract infections (LRTI) in their infants up to 6 months of age” (GRACE). The GRACE trial will be conducted at the Maternity of Hospital Clinic, one of the participating sites of this multicenter international trial, and will enrol pregnant women and their newborns. This study will be co-led by ISGlobal and Hospital Clínic.
The primary objective of this trial is to assess the efficacy of a single dose of the RSV Maternal vaccine administered to maternal participants in preventing medically assessed, RSV-associated severe (including very severe) LRTIs in their infant participants up to 6 months of age. GRACE is a 30 months study funded by GSK.

Field research

  • Medical sciences.

Training and experience/Qualifications

  • Excellent communication and collaboration skills, experience working in diverse cultures
  • Required:

  • At least 5 years of experience across all stages of the clinical trial lifecycle, i.e. from protocol development to final study report.

  • Experience managing clinical trials funded from the commercial and development funding sectors, site development and support trial/s under first-tier regulatory review

  • Minimum of BSc or health/science degree equivalent

  • Current ICH/GCP certification

  • Preferred:

-Previous experience in randomized clinical trials, either drugs or vaccines

-Candidates with medical degree will be prioritized

Specific Requirements:

  • Results-oriented approach
  • High professional standards for clinical trial execution, monitoring and reporting
  • Accustomed to team work and willingness to contribute to elements outside the clinical trial scope
  • Ability to work under pressure
  • Ability to work independently where necessary

Key Responsibilities

  • Supports the clinical research teams in the full spectrum of the trial including:

  • Protocol compliance

  • Trial management activities from start up to close out

  • Development of trial tools and templates

  • Management and coordination with clinical trial monitors

  • Review and approval of monitoring reports

  • Review and approval of monitor timesheets and expenses

  • Site management and closure

  • Trial tracking

  • Ensure that all subject research activities undertaken in field sites as part of the GRACE project are conducted according to the standards of ICH-Good Clinical Practice (GCP), 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.

  • Oversees and coordinates the process for pharmacovigilance/safety of the trial.

  • 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 PIs as required.

  • Risk identification and escalation to the PIs.

  • Issue identification and applicable escalation to the PIs.

  • Participates in site initiation visits and assists with HSR training of field staff.

  • Attends meetings as required. Presents data as required.

  • Contributes to funder reports.

Specific Duties

  • This position requires to be based in Barcelona.

Skills

  • Teamwork
  • Problem resolution
  • Learning capacity

Language level

  • Excellent written and spoken Spanish
  • Excellent written and spoken English

Conditions

  • Duration:One year
  • Starting date: As soon as possible
  • Contract: Part time
  • Salary Range: Compensation for this position will be based on the applicant’s experience and qualifications.

During the crisis caused by COVID19, standard working conditions will be adapted to sanitary requirements.

How to apply

How to apply

Applicants must fill in the request form and include the following code reference position: CTM_GRASE_Jun21, 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 the position is filled.

Only shortlisted candidates will be contacted.

Only the applications submitted through the request form will be considered.

The interviews could be placed during the reception candidatures period.

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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, sex, marital status, race, ethnicity, disabilities, political leanings, religion or sexual orientation.