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Company Profile:
For over 25 years PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, we supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. We have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world. For more information about PAREXEL International visit www.PAREXEL.com.

Description:
Key Accountabilities
-Negotiate contracts between sponsor and sites.
-Collect and review site regulatory documents.
-Assure that project tracking and CTMS is up to date and accurate to meet the project related timelines and contractual obligations.
-Participate in the ongoing identification and maintenance of project-specific 'Fallback Language' log.
-Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and PAREXEL WSOPs.
-Participate in Clinical Operations meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
-Participate in PXL and department system/standards improvement activities.
-Provide weekly trackers and accurate monthly metrics in a timely manner to Clinical Operations management.

Skills
-Ability to successfully manage a full work-load across multiple-projects.
-Above average interpersonal skills.
-Ability to understand and maintain client confidentiality
-Interpersonal skills and ability to manage multiple projects required.
-Extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
-Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook. Database.
-Solid negotiation, analytical and problem-solving skills.
-Organized with good oral and written communication skills.

Experience:
Education
-4-year degree or relevant clinical or business equivalent.

Language Skills
-English

Minimum Work Experience
-Minimum of 1-2 years work experience, six-months of which has been involved in contract negotiation, site regulatory document collection and review, and/or clinical site monitoring.

PAREXEL is an Equal Opportunity Employer that develops strength through diversity. Please visit our web site at www.parexel.com.