Sr. Clinical Data Coordinator

ProPharma Group; Northern (KY); Hybrid; USD 70,000 - 110,000; Part time

Job summary

ProPharma Group in the United States is seeking a Senior Clinical Data Coordinator to support Phase I-III trials in accordance with ICH/GCP. You will perform data review, reconcile third party data streams and SAE data with the safety database, and conduct UAT of clinical databases.

The role requires a Bachelor's degree or allied health certification, at least 3 years of data management, and experience with EDC systems (Oracle Inform).

Qualifications

• Bachelor's degree OR certification in a related allied health profession.
• Minimum of 3 years of data management experience is required.
• Experience with Electronic Data Capture (EDC) systems is required.

Responsibilities

• Perform ongoing data review, including reconciliation of third party data streams and SAE reconciliation with the safety database.
• Perform User Acceptance Testing (UAT) of clinical databases.
• Perform Quality Control (QC) of clinical databases.

Skills

Data management

EDC systems

UAT testing

QC

Documentation

Education

Bachelor's degree or allied health certification

Tools

InformTM EDC

Job description

## Sr. Clinical Data CoordinatorApplylocations: United Statestime type: Full timeposted on: Posted Yesterdayjob requisition id: JR 10393For 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 InformTM EDC system is preferred.* Oncology and/or inflammatory therapeutic area experience is preferred.#LI-REMOTE#LI-AP1We 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.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.\*\*\*ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.\*\*\*