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Study Start Up Specialist - office based in Bratislava, Slovakia
Labcorp
Place of work
Slovakia, Bratislava
Slovakia, Bratislava
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
Our current growth of Clinical Development Services (CDS) in Eastern European countries brings new opportunities not only for clinical roles, but also another business functions.
At the moment we are looking for Study Start Up Specialist.
This is a permanent, full time position, office based role in our office in Bratislava.
Responsibilities:
Delivery of the Global Site Services (GSS) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
Primary contact with investigative sites during site start-up activities
Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor
Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
Our current growth of Clinical Development Services (CDS) in Eastern European countries brings new opportunities not only for clinical roles, but also another business functions.
At the moment we are looking for Study Start Up Specialist.
This is a permanent, full time position, office based role in our office in Bratislava.
Responsibilities:
Delivery of the Global Site Services (GSS) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
Primary contact with investigative sites during site start-up activities
Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor
Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of
Employee perks, benefits
Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
Information about the selection process
If you are interested in a Covance opportunity and would like to apply, please visit our website at covancecareers.com and look for the reference 60686BR.
You can also follow the link:
You can also follow the link:
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
University education (Master's degree)
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
University/College degree
Previous experience in CRO/pharma company on similar position
Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
Good organizational and time management skills
Excellent communication / writing skills
Strong computer skills with an ability to access and leverage technology alternatives
Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in a team environment
Detail and process oriented
Positive attitude and approach
Multi-tasking capability
Ability to work independently
Fluency in local and English language
Previous experience in CRO/pharma company on similar position
Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
Good organizational and time management skills
Excellent communication / writing skills
Strong computer skills with an ability to access and leverage technology alternatives
Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in a team environment
Detail and process oriented
Positive attitude and approach
Multi-tasking capability
Ability to work independently
Fluency in local and English language
Advertiser
Brief description of the company
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ID: 2539441
Dátum zverejnenia: 29.4.2016
2016-04-29
lokalita: Bratislava Pozícia: Account Manager, Business Analyst, IT Analyst, IT Consultant, Medical Advisor Spoločnosť: Labcorp