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R&D Compliance Manager Palo Alto United States,  


Posted on : 25 June 2017

Project Description

Responsible for the maintenance of Trial Master File related records and documents, including but not limited to receiving, reviewing, indexing, scanning, filing, to ensure compliance with relevant regulatory, legal and corporate requirements and the effective and efficient management of the trial master file records and related information.Essential Functions Manages the the review, filing, archival, tracking and retrieval processes for completed TMF related documents stored on or off site.Maintains integrity of TMF storage area (room access, closure, etc.) and orchestrate off-site storage processesManages document review requests and resolve documentation issuesCreates and maintain database of all documents, paper or electronic, including exact locationLeads the clinical document control efforts in preparing for and participating in an audit and/or regulatory inspection.Supports the implementation and management of electronic and paper Clinical Trial/TMF DocumentationSupports the management of Clinical Study Records life cycle, including retention and disposition of records and associated audit trails in accordance with best business practices, applicable regulations and corporate policies and proceduresSupports the creation and execution of clinical documentation TMF trainingServes as a liaison for internal/external customersSupports R&D Clinical Compliance in providing measures of performance such as Metrics and KPI for continuous improvementSupports the transition of proprietary information for acquisitions, divestitures and licensing of compounds related to trial master file recordsSupports other R&D Compliance projects as neededSupports the maintenance of TMF Index Required Knowledge, Skills, and Abilities Experience in Trial Master File requirements and set-upKnowledge of DIA filing structureKnowledge of global regulatory requirements and ICH/GCP guidelinesWorking knowledge with electronic document management systems and document archival systems (eTMF)Demonstrated ability to work independently and in a team environmentStrong organizational abilities, action oriented and strong communciation skillsAble to carry out responsibilities with minimal to no supervisionKnowledge of document management processes and procedures, electronic documentation systems, data retrieval, and electronic file formatsAbility to demonstrate initiative.Ability to plan and organize work in an efficient manner, and work well under time constraints. Required/Preferred Education and LicensesBachelor Degree or minimum of 3 years directly related experience Clinical Trials, TMF and clinical systems and processProficiency with MS Office (e.g. Word, Excel, PowerPoint, Visio, Outlook) Description of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery. Description of Work EnvironmentWork indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel.  Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.

Locations

Palo Alto California

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