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Observational Research Specialist Ii

Observational Research Specialist Ii
Empresa:

Mygwork


Detalles de la oferta

Job Purpose: Independently provide site management and support activities for Observational/ Non-interventional
research study sites in accordance with relevant Standard Operating Procedures (SOPs),
study-specific procedures and regulations.

Key Accountabilities:

Depending on study assignment and with support as necessary key accountabilities are:

o Primary contact for assigned sites and build positive business relationships with physicians and
site staff.

o Site identification, selection and start-up activities including negotiation of site agreements
and budgets.

o Demonstrate protocol expertise.

o Customization of country/site specific documentation.

o Conduct of all remote and on-site monitoring activities through all study stages.

o Proactive issue management with a focus on issue prevention.

o Identification of potential out of scope activities.

o Perform regular reviews of data according to Site Management Plan (SMP).

Regularly inform manager, ORL and PL (as needed) of status of work.

o Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology
Practices

(GPP) guidelines, local country requirements, SOPs and study specific procedures

Qualifications

Skills:

• Excellent interpersonal, verbal and written communication skills in English (and local language
as necessary).

• Excellent customer focus and able to interact professionally with a client organization and study
site.

• Strong computer skills, familiar with MS-Office products including Excel, Word and PowerPoint,
Clinical Trial

Management and EDC systems:

• Thorough knowledge of Observational/ Non-interventional study research and relevant regulations
including GPP.

• Ability to work in a 'virtual' team environment as well as work independently, seeking guidance
as appropriate.

• Consistently delivers work to 'First Time Quality' whilst managing time effectively to meet
metrics and/or team objectives.

• Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve
study timelines.

• Willing to travel locally and internationally as necessary.

• Seeks opportunities to develop experience and knowledge making suggestions to enhance service
delivery.

Knowledge and Experience:

• Clinical Monitoring, Data Management and/or research experience with a solid understanding of
Observational/ Non-interventional research methodology and terminology.

Education:

• Degree in a life science, nursing qualification or other relevant experience required

This employer is a corporate member of
myGwork, the business community for LGBTQ+ professionals,
graduates, inclusive employers & anyone who believes in workplace equality.


Fuente: Allthetopbananas_Ppc

Requisitos

Observational Research Specialist Ii
Empresa:

Mygwork


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