1. CLINICAL TRIALS REGULATORY AFFAIRS MANAGER
Minimum Qualifications:
§ Professional degree (preferably M.D. or Ph.D.) at least five (5) years experience at a clinical research facility or in the pharmaceutical industry managing regulatory aspects of clinical trials involving investigational new drugs or medical products;
§ English Level IV proficiency including Bahasa Indonesia (writing and reading);
§ Demonstrate a good working knowledge of the planning and execution of clinical trials from an ethical and regulatory standpoint;
§ Must be well versed in the standards of Good Clinical Practice (GCP) and have experience in the management of adverse event reporting, compliance with FDA regulations and pharmaceutical sponsor requirements, Case Report Form (CRF) quality assurance, data storage, and retrieval procedures, data query management, and regulatory auditing procedures; and
§ Must have good working knowledge of standard word processing, spreadsheet, and data/retrieval software.
Duties:
§ As clinical trials regulatory manager, the employee is responsible for managing all regulatory aspects of the clinical trials involving Investigational New Drugs (INDs) conducted at company by the Parasitic Diseases Program.
§ The employee will serve as the primary consultant to the clinical trial principal investigator and serve as the liaison to the pharmaceutical industry sponsor representative and U.S. FDA on regulatory matters.
§ The employee will audit and ensure that investigators are meeting regulatory requirements and complying with sponsor requests during the planning and execution stages of the clinical trials to which the employee is assigned.
§ These activities include but are not limited to clinical trial agreements, FDA 1572 maintenance, source document agreements, source data verification procedures, financial disclosure agreements assurances, authorized signatures form maintenance, managing data queries, ensuring timely and accurate completion of CRFs, and preparing for audits.
§ The employee will have supervisory authority over one other contract employees, the GCP assistant in the Department of GCP and Quality Assurance.
§ The employee will be required to periodically go to rural field sites where clinical trials are being conducted to address regulatory issues that cannot be addressed at company, Jakarta. This travel may require overnight stays for one or several nights in these rural locations.
Please send your CV to email executivesearch@moores-rowland.com with subject email ‘CTR’. Thank’s
Best regards
PT Moores Rowland Indonesia
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