Clinical Operations Project Manager

Dina J. Alsafi

(+***) 774-***-**** ad4r4u@r.postjobfree.com

Operation Assistant

Self-motivated, proactive professional with over six years of operations and project coordination career in various aspects. My strength lies in my ability to adapt quickly to changing demands, time management and agile leadership. I have a keen eye for strategic problem-solving and detail orientation. Capable and willing to work with tight deadlines. Familiar with working in multicultural environment businesses. Enthusiastic learner, quickly mastered software and data systems. Possesses excellent oral and writing skills in Arabic and English and a good command of Kurdish.

Career experience

Operation Specialist Clinical Operations Rho, Inc., Durham, NC Dec. 2022- Sep.2023

·Managed daily operations activities for the Product Safety department, data-sensitive collection and document preparation, data analysis, report writing, and utilizing the information in the systems.

·Supported the development of a working guide and (SOP) Standard Of Processes for global expansion.

·Initiated gap assessment for department training to improve capacity-building standardization.

·Facilitated cross-channel feedback between clients, external partners, and management teams.

·Ensured all activities conform to local, federal, industry, and company standards.

Project Assistant Clinical Operations Rho, Inc., Durham, NC Jan.2022-Dec. 2022

·Assisted the project management team, external partners, and clients with document submission.

·Delivered internal and external correspondence on project development and industrial updates.

·Coordinated the regulatory document compliance collection and approval process.

·Maintained the external partner's registration portal and internal project tracking tools.

·Trained junior Research Associates and supported external staff with learning and development tools.

Managed a small business start-up food catering service Erbil, Iraq. Jun.2019- Feb.2020

Accountability Unit Operations Manager NGO contract Erbil, Iraq. Apr. 2018-Apr.2019

NGO Project Manager NGO contract Jan.2017-Dec.2017 Erbil, Iraq. Dec. 2016-Jun. 2017

Regulatory Specialist Regulatory Reporting IQVIA U.S.A. Nov. 2015- Nov. 2016

·Ensured the company projects were in compliance with rules and regulatory standards for the industry.

·Obtained project information, analyzed data, and prepared documents for FDA regulatory submissions.

·Reviewed protocol documentation according to regulatory compliance in preparation for audit review.

·Created work instructions guide and trained junior staff.

Program Monitoring Officer NGO contract Erbil, Iraq. Dec.2013-Mar2014.

Safety Operations Coordinator I Drug Safety IQVIA, Durham, NC, U.S.A. Jul. 2010 – Oct. 2013

·Analyzed data and coordinated workflow among teams for the drug safety clinical department.

· Performed pharmacovigilance activities in a clinical trial study with 22,000 subjects worldwide, collecting and tracking clinical data for adverse events cases.

·Managed a multinational site's case monitoring, tracking, archival, and project filing process.

· Liaised with client's meetings and coordinated communication materials with external partners

Education

Bachelor of Arts. English major. Babylon University, Iraq.

Certification

·Good Clinical Practice, certificate by FDA

·Reporting Tools Development by U.S.A. Embassy

·Project Initiation and Planning, Certificate, Revira, U.S.A.

·Training of Trainers, certificate by UNFPA

Skills

●Microsoft Professional Google Docs Dropbox CTM(Clinical Trial Management Argus Oracle Veeva Point of Sale.

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