Sr. Clinical Data Coordinator

ProPharma; Raleigh (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

ProPharma in the United States is seeking a Senior Clinical Data Coordinator (FSP/Contractor) to oversee data management activities for Phase I–III clinical trials, ensuring the data are accurate, timely, and compliant with ICH/GCP guidelines. You will perform data review, UAT of clinical databases, QC routines, and maintain Data Management documentation, contributing to high-quality deliverables and project timelines.

Experience with EDC systems such as Oracle Inform is required or preferred.

Qualifications

• Bachelor's degree or allied health certification required or equivalent experience.
• Minimum 3 years of data management experience.
• Experience with Electronic Data Capture (EDC) systems required.
• Oracle Inform EDC experience preferred.
• Oncology or inflammatory therapeutic area experience preferred.

Responsibilities

• Perform ongoing data review, including reconciliation of data streams and SAE reconciliation with the safety database.
• Perform User Acceptance Testing (UAT) of clinical databases.
• Perform Quality Control (QC) of clinical databases.
• Update Data Management documentation as needed.

Skills

Data management

Quality control

UAT testing

Documentation updates

Education

Bachelor's degree or allied health certification

Tools

Oracle Inform EDC

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Title: Senior Clinical Data Coordinator

FSP/Contractor

Job Summary

The Sr. Clinical Data Coordinator performs activities pertaining to the conduct of Phase I-IlI clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Summary Of The Essential Functions Of The Job

• Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database.
• Perform User Acceptance Testing (UAT) of clinical databases.
• Perform Quality Control (QC) of clinical databases.
• Perform ongoing updates of Data Management-related documentation, as needed.

Minimum Requirements

• Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
• Minimum of 3 years of data management experience is required.
• Experience with Electronic Data Capture (EDC) system(s) is required.
• Experience with Oracle Inc.'s Inform™ EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.