...site are in place and maintained
Ensure timely collection, documentation and reporting of Adverse events (AEs) and Serious AEs (SAEs) and collaborate in submission of the reports to FDA, EMEA and other applicable regulatory authorities
Ensure supportive relationships...
Suggéré
Emploi contractuel
Stage
argenx SE
Gand
il y a 5 jours
...~Communication with the participating investigators to resolve queries and collect missing data
~Performing the reconciliation of SAEs with the clinical database when applicable
Other
~Development and maintenance of the data management plan
~Preparation and attendance...
Suggéré
Stage
Emploi contractuel
Temps complet
Travail à domicile
...Set-up and manage safety board and/or Imaging Core Lab.
Ensure correct and timely Adverse Event (AE) and Serious Adverse Event (SAE) reporting and follow-up.
Perform reconciliation of the Trial Master File (TMF) content to Investigator Site Files (ISF).
Develop...
Suggéré
Temps complet
Emploi contractuel
À distance
Travail à domicile
BeCRO, the Belgian Association of CROs
Belgique
il y a 2 jours
...deliveries, safety issue management…)
Training capability in Safety
Ability to allocate/drive activities performed by others (SAE)
TECHNICAL COMPETENCIES & EXPERIENCE
Mandatory:
Mastering Cenelec Standards for Safety (or equivalent standards if needed...
Suggéré
ALSTOM Gruppe
Charleroi
il y a 4 jours
...Understanding of Design Patterns (e.g. MVC - Model-View-Controller, MVVM – Model- View-ViewModel)
7. CAN (Controller Area Network) SAE J1939 communications experience is considered a plus
8. Familiarity with TCP/IP networking protocols and sockets programming
9....
Suggéré
...solutions (Projects and Programs)
Manage Safety resources (SAMs, SAEs) in skill and quantity (workload and delivery on time) (*safety... ...Safety Assurance Managers (PSAM), Safety Assurance Engineers (SAE)
Network & Links
Internal
Project or Program Core team...
Suggéré
...the site staff for ensuring a proper reporting from the site of the safety events (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
Actively participates in project...
Suggéré
Travail posté
...Support II (STAQSS II) contract.
AQX provides expert advice and integrated acquisition positions to the Service Acquisition Executive (SAE), AF leadership, PEOs and Program Managers (PMs) on planning, programming, budgeting, execution, and acquisition oversight/reporting...
Suggéré
Emploi contractuel
Pour les contractants
À distance
Recrutement immédiat
OBXtek
Bruxelles
il y a 18 heures
...quality information for Air Force senior leaders.
Tasks for this position include:
a. Supporting HAF budget preparation and defense, SAE oversight and decision-making activities, PEO program execution and oversight efforts of aircraft platforms.b. Maintaining and...
Suggéré
Emploi contractuel
Pour les contractants
Emploi en CDD
À distance
OBXtek
Bruxelles
il y a 18 heures
...Command, Control, and Communications) programs.
Tasks for this position include:
Supporting HAF budget preparation and defense, SAE oversight and decision-making activities, PEO program execution and oversight efforts of space systems.
Maintaining and analyzing...
Suggéré
Emploi contractuel
Pour les contractants
Emploi intérim
Emploi en CDD
OBXtek
Bruxelles
il y a 2 jours
Acquisition Program Analyst, Journeyman (NATO Programs for AQI - Information Dominance Programs[...]
...include:
Building documentation, reviewing data, and providing impartial assessments in support of HAF budget preparation and defense, SAE oversight and decision-making activities, Program Executive Office (PEO) execution and oversight efforts of Air Force Information...
Suggéré
Emploi contractuel
Pour les contractants
Emploi en CDD
À distance
OBXtek
Bruxelles
il y a 2 jours
...100% onsite, based on the mission's needs.
The tasks for this position include:
Supporting HAF budget preparation and defense, SAE oversight and decision-making activities, PEO program execution and oversight efforts of aircraft platforms.
Maintaining and analyzing...
Suggéré
Emploi contractuel
Pour les contractants
Emploi en CDD
À distance
OBXtek
Bruxelles
il y a 2 jours