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Amanda Nadifi

Founder of Kesh Research Group LLC/

Clinical Data Management Consultant

Phone:

910-514-4063

Email:

Address:

Remote- Garner, NC 27529

Feature Spotlight: Meet the Founder

From Nursing to Data Management

Amanda Nadifi’s career trajectory took an unexpected turn—a twist of fate, if you will. As a high school student, she completed her certified nursing assistant (CNA) certificate, fully intending to pursue a path in healthcare. However, destiny had other plans. During her college years at Campbell University, Amanda discovered the captivating world of clinical research. It was there that she found her true calling.

 

The Pivotal Moment

Amanda’s pivotal moment came during a data management class. As she delved into the intricacies of managing clinical trial data, she realized that this field perfectly aligned with her career aspirations. Her analytical mind, attention to detail, and passion for improving patient outcomes found a home in clinical data management.

 

Climbing the Ranks

Amanda started her journey as an entry-level Clinical Data Coordinator. Her determination and expertise propelled her upward through the ranks. She honed her skills, navigated complex projects, and contributed significantly to the success of clinical trials. Over seventeen years in the data management industry, she became a Senior Manager in Data Management, overseeing critical processes and ensuring data quality.

 

A Leap into Consulting

Yet, Amanda yearned for something more—a chance to make an even broader impact. That desire led her to take a leap into the world of consulting. In founding Kesh Research Group, she aimed to unlock excellence in clinical data management through expert consulting services. Her vision was clear: to bridge the gap between research, data, and patient well-being.

 

Kesh Research Group: Unlocking Excellence

At Kesh Research Group, Amanda brings her wealth of experience to the table. She collaborates with pharmaceutical and biotech companies as well as research institutions, providing strategic guidance, optimizing data processes, and ensuring regulatory compliance. Amanda’s unwavering commitment to quality and patient-centric data management shines through in every project.

 

Conclusion

Amanda Nadifi’s journey—from nursing to data management to consulting—exemplifies resilience, adaptability, and a passion for making a difference. Her unwavering dedication to improving clinical research outcomes continues to inspire those around her.

Work Experience

Jul 2024 - Present

Mar 2024 - Jul 2024

Oct 2023 - Feb 2024

Jul 2023 - Oct 2023

Mar 2021 - Jul 2023

Feb 2019 - Mar 2021

Oct 2017 - Feb 2019

Founder/ Clinical Data Management Consultant

  • Serves as Clinical Data Management Consultant for the following services (including but not limited to): ​

    • CRO Oversight

    • Head/Manager of Data Management Team

    • Hands-on Data Management Activities

    • Process and Training Development

Sabbatical​

Head of FSP, Data Management

  • Served as the main point of contact for all FSP clients 

  • Served as Line Manager and managed a team of 16 direct reports 

  • Participated in the recruiting, hiring, and on-boarding of employees 

  • Served as Program level DM Oversight for 6 studies outsourced to CROs

Senior Manager, Data Management

  • Served as FSP Manager for 1 new client and handled all the recruiting, hiring, onboarding and managing of FSP employees for this client. Also attended the Executive Committee Meeting.

  • Served as Line Manager and managed a team of 10 direct reports 

  • Participated in the recruiting, hiring, and on-boarding of employees 

  • Participated in the development and review of processes and standards for the Data Management department. Acted as Lead Reviewer for US DM from Jul2023 to Dec2023.

Manager, Data Management​

  • Served as Line Manager and built and managed a team of 8 direct reports 

  • Participated in the recruiting, hiring, and on-boarding of employees 

  • Served as a Trainer on the SOPs/WIs/Training documents/Templates for the US Data Management Team. Acted as Lead Trainer for US DM from Jan2023- Jun2023.

Project Manager​

  • Acted as Project Manager for up to 30 studies at a time across 8 sponsors

  • Oversaw the Data Management, Biostatistics, Programming, and Medical Writing tasks for assigned studies

  • Established and monitored project controls for timeline, scope and budget

Senior Clinical Data Manager​

  • Acted as Lead Data Manager for 6 studies

  • Took ownership of, monitored and ensured adherence to study timelines and deliverables.

  • Coordinated with the programming team regarding any database or programming changes needed throughout the study.

  • Identified data trends and reported study inconsistencies to applicable study team personnel, then we worked together to develop and implement an action plan.

910-514-4063

Garner, NC 27529, USA

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