Manager, Regulatory and Research Records Management

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FHI 360

Req #: 18082
Type: Full-Time
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FHI 360

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				About FHI 360

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research and technology - creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories. We are currently seeking qualified candidates for the position of: Manager, Regulatory & Research Records Management

Description

Creates, reviews and assists with IND submissions to FDA and regulatory submissions to other regulatory authorities outside the US.

Job Summary / Responsibilities

*  Manages staff that maintains the collection of clinical and regulatory documents for research projects. Oversees the planning, directing and executing of archiving documents and record management for multiple projects. Ensures documents, records and Trial Master Files (TMFs) are complete, safe, and accessible for internal and external audits. Develops and provides instruction with study set-up, scanning, indexing, filing, and audit preparation. Creates and implements strategies to support company's clinical research and regulatory records management. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. 

*  Provides leadership and expertise in records management and archiving support for clinical research studies. 

*  Sets objectives for electronic records program, implementation and roll-out. 

*  Oversees the deployment and implementation of global records management software and associated processes. 

*  Develops policies and best practices in compliance with corporate, legal, and regulatory requirements with records management. 

*  Coaches, mentors and provides training to staff and functional areas and assists with the development of training sessions to ensure compliance with records management requirements. 

*  Collaborates with cross functional areas and external personnel on the functionality and details of the organization's regulatory and records retention processes. 

*  Writes and provides input into SOPs and work plans to ensure adherence to processes which affect Central Clinical Files. 

*  Develops and monitors budgetary responsibilities for assigned projects. 

*  Plans initiatives for department and participates in implementing action plans for improvements.

Qualifications

*  Bachelor's Degree or its International Equivalent - Life Sciences, Communications, Journalism, Public Health or Related Field. 

*  Typically requires 5-8 years of records retention management experience. 

*  Articulate, professional and able to communicate in a clear, positive manner with clients and staff. 

*  Must be able to read, write and speak fluent English. 

*  Prior management experience preferred. 

*  Prior work in a non-governmental organization (NGO).

This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

We offer competitive compensation and an outstanding benefit package. Please click here to visit FHI 360's Career Center for a list of all open positions.

FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
			
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