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Clinical Research Associates
AXON Neuroscience SE
Place of work
Dvořákovo nábrežie 10, Bratislava
Dvořákovo nábrežie 10, Bratislava
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
The candidate will play a vital role in clinical trials, ensuring that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) and perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH, GCP, FDA regulations, local regulations, Standard Operating Procedures (SOPs) and Study Protocol. Position will be initially office based with a possibility of home based depending on the stage of the project and agreement with the Line Manager.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Driving licence
B
Number of years of experience
1
Personality requirements and skills
- Effective clinical monitoring skills
- Excellent understanding and demonstrated application of Good
Clinical Practices and applicable Standard Operating Procedures.
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients
- Demonstrated understanding of medical/therapeutic area knowledge
- Effective organizational and time management skills
- Proven flexibility and adaptability
- Ability to work in a team or independently as required
- Good presentation skills
- Ability to effectively prioritize tasks
- Attention to detail
- Computer literacy, proficiency in Microsoft Office
Number of years of experience:
1 or more years of experience independently monitoring clinical trials for drug studies
Language skills:
English – fluent
Slovak or Czech – advanced
German – candidates with fluent German will be preferred
- Excellent understanding and demonstrated application of Good
Clinical Practices and applicable Standard Operating Procedures.
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients
- Demonstrated understanding of medical/therapeutic area knowledge
- Effective organizational and time management skills
- Proven flexibility and adaptability
- Ability to work in a team or independently as required
- Good presentation skills
- Ability to effectively prioritize tasks
- Attention to detail
- Computer literacy, proficiency in Microsoft Office
Number of years of experience:
1 or more years of experience independently monitoring clinical trials for drug studies
Language skills:
English – fluent
Slovak or Czech – advanced
German – candidates with fluent German will be preferred
Advertiser
Brief description of the company
AXON Neuroscience is a biotech company dedicated to the development of disease modifying immunotherapy and early diagnostics for Alzheimer’s disease and other tauopathies. The company is highly experienced in the research of tau pathologies with a large scientific team working on tau worldwide. AXON Neuroscience has exclusive access to and experience with tau-based animal models. AADvac1, the active vaccine against pathological tau protein, is the leader in the company development pipeline. Recently, the company has completed its phase I study and is entering the phase II development program.
Number of employees
50-99 employees
ID: 2326724
Dátum zverejnenia: 12.11.2015
2015-11-12
lokalita: Bratislava Pozícia: Clinical Data Manager, Clinical Research Associate Spoločnosť: AXON Neuroscience SE