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Clinical Data Manager
SanaClis s.r.o.
Place of work
Prague, Czechia
Prague, Czechia
Contract type
full-time
full-time
Start date
ASAP
ASAP
Wage (gross)
72 000 Kč/monththe final salary will be based on mutual agreement and will reflect experience and qualification of a job candidate
72 000 Kč/monththe final salary will be based on mutual agreement and will reflect experience and qualification of a job candidate
Information about the position
Job description, responsibilities and duties
We are looking for a new colleague on the position of Clinical Data Manager.
If you are enthusiastic about data and clinical research, independent and responsible, with experience in data management and fluent in English, we would be glad, if you consider the following job offer.
We are looking for experienced Clinical Data Manager. Depending from your location, you might work from the office or from home.
Job responsibilities:
In cooperation with our team, you will make sure, that clinical trial data is collected, managed and reported clearly, accurately and securely.
You will manage all aspects of the clinical trial data management process from study start-up to database lock. We expect you to contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation. You will develop project-specific data management plans, that would address such areas as coding, reporting, transfer, database locks and workflow processes. You will design eCRFs, write instruction manuals, data capture guidelines, cleaning guidelines or SOPs; design and validate clinical databases including designing or testing logic checks.
Important part of your work will also be the review of clinical trial data in accordance with standardized data management processes to identify erroneous and missing data, generating, resolving and tracking queries to address problematic data identified during data review activities.
You will also ensure compliance with applicable international Guidelines, local and international regulatory requirements, SOPs, and study specific requirements.
Continuous improvement of your knowledge and skills, review of the best practices, industry standards and development and research technologies/procedures for improving our data management practices.
You will work closely with our DM, PV and ClinOps teams, provide support in data management areas, train and mentor other colleagues to reach the highest possible standards.
If you are enthusiastic about data and clinical research, independent and responsible, with experience in data management and fluent in English, we would be glad, if you consider the following job offer.
We are looking for experienced Clinical Data Manager. Depending from your location, you might work from the office or from home.
Job responsibilities:
In cooperation with our team, you will make sure, that clinical trial data is collected, managed and reported clearly, accurately and securely.
You will manage all aspects of the clinical trial data management process from study start-up to database lock. We expect you to contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation. You will develop project-specific data management plans, that would address such areas as coding, reporting, transfer, database locks and workflow processes. You will design eCRFs, write instruction manuals, data capture guidelines, cleaning guidelines or SOPs; design and validate clinical databases including designing or testing logic checks.
Important part of your work will also be the review of clinical trial data in accordance with standardized data management processes to identify erroneous and missing data, generating, resolving and tracking queries to address problematic data identified during data review activities.
You will also ensure compliance with applicable international Guidelines, local and international regulatory requirements, SOPs, and study specific requirements.
Continuous improvement of your knowledge and skills, review of the best practices, industry standards and development and research technologies/procedures for improving our data management practices.
You will work closely with our DM, PV and ClinOps teams, provide support in data management areas, train and mentor other colleagues to reach the highest possible standards.
Employee perks, benefits
will be specified during the job interview
Information about the selection process
The communication language in our company is English, so we expect you would be fluent speaker. Knowledge of other languages is considered an advantage.
We expect you would have profound knowledge of Clinical trial industry, Clinical data management and ICH GCP.
We expect you would have profound knowledge of Clinical trial industry, Clinical data management and ICH GCP.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Educational Specialization
life science, computer science, bioinformatics, or similar...
Language skills
English - Advanced (C1)
Other knowledge
Microsoft Office - Advanced
superior computer literacy - Advanced
superior computer literacy - Advanced
Experience in the position/sector
clinical trials, data management, or other relevant
Number of years of experience
2
Personality requirements and skills
You should demonstrate the ability to build and maintain effective relationships with others and establish collaborative partnerships with internal and external stakeholders. You should be able to manage a team, including remote and international teams, mentor, guide and train other colleagues.
We expect you to be self-disciplined and able to work effectively without immediate supervision, results-oriented; able to set and meet short-term and long-term goals and manage multiple tasks with high attention to details and logical thinking.
We expect you to be self-disciplined and able to work effectively without immediate supervision, results-oriented; able to set and meet short-term and long-term goals and manage multiple tasks with high attention to details and logical thinking.
Advertiser
Brief description of the company
SanaClis is a full-service European CRO offering a comprehensive range of services for clinical trials. In additional to being a full-service CRO, SanaClis is one from very few CROs in the world who has in-house logistics capabilities. This includes QP services, customs brokerage, warehousing and distribution, and sourcing of clinical trial materials, comparators and rescue medication.
ID: 3978046
Dátum zverejnenia: 14.2.2021
2021-02-14
lokalita: Prague Pozícia: Clinical Data Manager, Database Administrator, Database Analyst Spoločnosť: SanaClis s.r.o.
Spodná hranica mzdy (brutto): 72 000 Kč/month