Sr. Clinical Data Coordinator

ProPharma • Raleigh, NC

1d • Remote

About The Position

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.

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.

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.

Nice To Haves

• Experience with Oracle Inc.'s Inform™ EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree