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PPD

Central Review Manager (home- or office-based)

 PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.
Now a great opportunity exists for:
 
Central Review Manager (home- or office-based)
 

Required Education and Experience:


• Life Science Degree and/or relevant qualification/experience;
• At least 3 years direct clinical monitoring experience as a clinical research associate that provides the knowledge, skills, and abilities to perform the job is required.
• In-depth understanding of ICH/GCP guidelines;
• Excellent standard of verbal and written communication skills in English;
• Highly organized with strong attention to detail and deadlines;
• Advanced skills across all of the Microsoft packages;

 

Responsibilities:

• Performs review of clinical monitoring visit reports ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.

• Liaises with CRA for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor.

• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study, as ascertained from information noted in monitoring visit reports and associated electronic data systems.

• Provides trial MVR status tracking and progress update reports to CTM/CRA as required.

• May assist project manager or clinical team manager on assigned projects.


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