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Position
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Senior Clinical Research Associate
Roles and Responsibilities
- Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
- Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
- Creating study relevant documents for submissions to competent authorities and ethics committees
- Be up to date with European and local regulatory requirements in clinical trials
- Participation in national and international project and investigational meetings
Requirements
- At least 3 years of experience as a CRA
- Team player with strong communication and collaboration skills
- Ability to work with investigational sites in Germany
- Excellent at planning, organising and executing trial activities
- Ability to prioritize tasks, while keeping attention to important details
- Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
- Willingness to travel
Location
Project Assistant
Roles and Responsibilities
- General administrative work
- Compilation of documents for submissions to ethics committees and regulatory authorities
- Compilation of documents to be appended to clinical study protocols and clinical study reports
- Compilation of investigators’ files according to given specifications
- Filing and tracking of documents in the different files (trial master file and project file)
- Assistance in scheduling of site visits
- Storage, dispatch and in-house accountability of investigational medicinal products and other study material
- Organization of investigators’ meetings
- Archiving and handing over Trial Master File to the sponsor
- First data entry in SAS
- Recruiting of new sites, telephone contacts to collect documents
- Investigator payments
Requirements
- Successfully completed Project Assistant training
- Knowledge of GCP principles
- Understanding of medical matters
- Good knowledge of English
- Good knowledge of Office software
- Knowledge of general Office procedures
- Adequate IT experience for electronic filing
Location
Senior Clinical Research Associate
Roles and Responsibilities
- Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
- Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
- Creating study relevant documents for submissions to competent authorities and ethics committees
- Be up to date with European and local regulatory requirements in clinical trials
- Participation in national and international project and investigational meetings
Requirements
- At least 3 years of experience as a CRA
- Team player with strong communication and collaboration skills
- Ability to work with investigational sites in Germany
- Excellent at planning, organising and executing trial activities
- Ability to prioritize tasks, while keeping attention to important details
- Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
- Willingness to travel
Location
Senior Clinical Research Associate
Roles and Responsibilities
- Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
- Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
- Creating study relevant documents for submissions to competent authorities and ethics committees
- Be up to date with European and local regulatory requirements in clinical trials
- Participation in national and international project and investigational meetings
Requirements
- At least 5 years of experience as a CRA
- Team player with strong communication and collaboration skills
- Ability to work with investigational sites in Denmark, Norway and Sweden
- Excellent at planning, organising and executing trial activities
- Ability to prioritize tasks, while keeping attention to important details
- Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
- Willingness to travel
Location
Senior Clinical Research Associate
Roles and Responsibilities
- Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
- Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
- Creating study relevant documents for submissions to competent authorities and ethics committees
- Be up to date with European and local regulatory requirements in clinical trials
- Participation in national and international project and investigational meetings
Requirements
- At least 5 years of experience as a CRA
- Team player with strong communication and collaboration skills
- Ability to work with investigational sites in Denmark, Norway and Sweden
- Excellent at planning, organising and executing trial activities
- Ability to prioritize tasks, while keeping attention to important details
- Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
- Willingness to travel
Location
- Home based in Czech Republic
Global Head of Biostatistics for Clinical Research
Roles and Responsibilities
- Global co-ordination and lead of the statistical group
- Biometric activities with regard to study protocols, sample size calculations, and data validation
- Preparation of statistical analysis plan
- Programming of statistical analyses, tables, figures, and listings
- Statistical reporting
- Preparation of data review and data review meeting
- Active support to improve standards and processes
- Communication with biometrician/statistician of sponsor
Requirements
- Degree in statistics or mathematics with statistics as subsidiary subject
- Sound knowledge of biostatistics
- Understanding of medical matters
- Experience in clinical trials of more than five years
- Sound knowledge of statistical program packages (SAS)
- Excellent command of written and spoken English
- For (non-native German: excellent command of written and spoken German)
Location
BD Executive
Roles and Responsibilities
- Build-up of business relationships as well as maintenance of existing business relations
- Acquisition of new clients
- Hunting activities by telephone, mailing activities, advertising, client meetings
- Preparation of business presentations and participation at client meetings as well as bid-defense meetings
- Participation in negotiations with clients
- Organisation and participation in national and international exhibitions and congresses
- Account Management duties
Requirements
- Profound experience in Clinical Research / GCP within CRO, pharmaceutical or biotech industry
- 3 years’ experience in the field of business development is preferred
- Study of medicine, veterinary medicine, or natural science is preferred
- Ability to learn quickly, show initiative and work as an effective team player
- Open-minded, enthusiastic and motivated personality with excellent communication and presentation skills
- Very good command of written and spoken English (good negotiation skills)
- Willingness to travel up to 70%
Location
- Office-based or home-based Europe
Clinical Investigator
Roles and Responsibilities
- Medical Screening of Healthy Volunteers ( History, Physical Examination, Laboratory tests , ECG and X-ray)
- Determination of Volunteer eligibility for Clinical Study as per Inclusion/exclusion Criteria of protocol
- Monitoring, Reporting and Management of Adverse Events/ Serious Adverse Events occurring during clinical study
- Maintenance of Emergency Drugs List and ICU set-up
Requirements
- 1 years or more general medical practice. Freshers can also be considered
- Candidates with experience in ICU and those who have undergone training in Basic Life Support/ Advanced Cardiovascular Life support will be preferred.
- Experience in Clinical Research/ Bioequivalence Studies is desirable
- Knowledge of kannada language is desirable
Location
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