Ref #: 26832

Employment type: Permanent - Full-Time

Location: Santiago

Posted: 11-Feb-2021

Description

Participate in the feasibility of studies with the client assigned Medical Advisor.
Produce, implement, analyze and follow recruitment plans and key milestones for assigned studies
Ensure study team members (local and global) are informed of study expectations,
plans and status
Oversee assigned studies, ensuring completion on schedule and within budget.
Ensure that all clinical studies are conducted according to Good Clinical Practice, ICH, Standard Operating Procedures, local laws, and Policies and Procedures.
Anticipate project requirements and institute appropriate actions to ensure timelines, quality standards, country commitments and budget are met.
Organize study specific training and regular team meetings for the local project team,
study staff and all client CSU functions as needed.
Accompany CRAs on pre-study, initiation, routine monitoring and close-out visits of study sites, when necessary and as oversight visits.

Collaborate closely with monitoring vendor and CSU designees to ensure study timelines, commitments, quality and expectations are known and met

Organize and participate in investigators or study meetings as needed.
Establish, track and maintain study specific trial management tools/systems
(IMPACT).
Ensure study files, payments and study data completion are up to date and thorough

COMMUNICATION (10 %)

Maintain regular contact with Medical Advisors, Medical Affairs, Monitoring team, global teams and all local client CSU functions in order to always be up to date on strategies and changes in the environment.
Negotiate and liaise in a professional manner with customers regarding all aspects of the project.
Collaborate with other client Clinical Study Unit Managers to present unified messages to client Clinical Study Unit personnel.

CRA Training certification is preferred
Bachelor’s degree in a scientific/medical discipline is required.
Must meet ACRP Core Competencies for Senior Level Monitor
Clinical Study Management experience preferred.
Experience in core aspects of clinical study management/oversight and/or
Minimum of 3 to 5 years of experience as a Clinical Research Associate
At least 8 years Clinical Research Experience or equivalent is required.
Advanced English is a MUST.