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Global Site Services Associate (Site Start up Associate).
Labcorp
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
At the moment, to our office in Rome, we are looking for:
Global Site Services Associate (Site Start up Associate).
As a GSS Associate you will be responsible for all aspects of supporting study start up activities of assigned project within local country or regionally.
Responsibilities:
• Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations
• Maintenance of allocated site’s information in the Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trial
• Working with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials
• Final review and approval of regulatory documentation for sites managed by another GSS professional (final independent review)
• Where applicable, provide logistical support for clinical trial supply coordination
Global Site Services Associate (Site Start up Associate).
As a GSS Associate you will be responsible for all aspects of supporting study start up activities of assigned project within local country or regionally.
Responsibilities:
• Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations
• Maintenance of allocated site’s information in the Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trial
• Working with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials
• Final review and approval of regulatory documentation for sites managed by another GSS professional (final independent review)
• Where applicable, provide logistical support for clinical trial supply coordination
Information about the selection process
In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package.
To apply please visit Covance career site at http://careers.covance.com/ quoting the appropriate reference number - 47108BR.
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
To apply please visit Covance career site at http://careers.covance.com/ quoting the appropriate reference number - 47108BR.
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Personality requirements and skills
Required Education and Experience:
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
• 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
• Feasibility study and study submissions experience required
• 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
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
• 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
• Feasibility study and study submissions experience required
• 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
Advertiser
Brief description of the company
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ID: 1785952
Dátum zverejnenia: 30.6.2014
2014-06-30
lokalita: Bratislava Pozícia: Clinical Data Manager, Service Technician Spoločnosť: Labcorp