Regulatory Submission Manager
Infotree Service Inc
Belgrano, Autonomous City of Buenos Aires, Argentina
hace 1 día
Job Description

•    Fully accountable for the success of project start-up;
•    Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications, including maintaining start-up timelines;
•    Maintain ongoing Sponsor contact for submission issues by serving as primary contact for Sponsor and project team members;
•    Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs), regulatory agencies, and the our client team;
•    Provide regulatory submissions advice and guidance to our client team to ensure compliance with appropriate regulations and requirements;
•    Quality check of submission documents;
•    Present during bid defenses, general capabilities meetings, and audits;
•    Provide oversight of Regulatory Submissions Coordinators and Clinical Trial Assistants; and
•    Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges. 

 


Qualifications

•    Bachelor’s degree and 4 years of clinical operations/study start-up experience; or master’s/PhD degree within life sciences and at least 3 years of clinical operations/study start-up experience



Additional Information

Great Benefits. 

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