Sr. Clinical Data Coordinator

propharmagroup; United States; Hybrid; USD 80,000 - 120,000; Full time

Benefits offered by this job

Remote work

Hybrid work options

Job summary

ProPharma is seeking a Senior Clinical Data Coordinator on a contract basis to support Phase I-III trials in compliance with ICH/GCP guidelines. The role focuses on data review, UAT, QC and documentation updates to ensure timely, high-quality deliverables.

Qualifications include a Bachelor's degree or related allied health certification and at least 3 years of data management experience with EDC systems (Oracle Inform EDC preferred).

Qualifications

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

Responsibilities

• Perform ongoing data review and reconciliation of data streams.
• Conduct User Acceptance Testing (UAT) of clinical databases.
• Perform Quality Control (QC) of clinical databases.
• Update Data Management documentation as needed.

Skills

Data management

EDC experience

UAT

QC

Documentation updates

Oracle Inform EDC

Clinical trial experience

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-III 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.

#LI-REMOTE

#LI-AP1

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.

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.