Clinical Quality Consultant

Job Description

We are looking for Clinical Quality Consultant. This is W2 role.

CPT/OPT/H4 EAD/H1b Candidates can apply.

* Establish and maintain our quality program.
* Develop and implement quality management systems.
* Draft and manage Quality Management Standard Operating Procedures (SOPs).
* Develop, manage, and execute the Corrective and Preventive Action (CAPA) process.
* Develop, manage, and execute internal data monitoring plans and data quality reviews.
* Conduct 10% Data Quality Reviews, this range may vary based upon current protocols.
* Develop, manage, and execute eligibility reviews.
* Ensure adherence to ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements.
* Ensure adherence to study protocols and proactively address site performance issues.
* Verify the accuracy of clinical data and manage any data discrepancies.
* Serve as a key communication conduit between study sites and the clinical operations management team.
* Manage oversight and accountability for timely reporting to external parties.
* Foster a culture of continuous improvement, leading initiatives to enhance efficiency, quality, and compliance across the organization.
* Serve as a point of escalation for the company on quality matters.
* Conduct and oversee vendor qualification visits
* Maintain the company level training matrix to ensure 100% training compliance across the organization.
* Establish and maintain an annual audit plan of all Topography clinical sites
* Be prepared to make training, resource, or performance evaluation recommendations based upon quality assurance findings.
* Serve as the main point of contact and internal owner of the quality management system.
* Direct line management of QA team members.
* Direct supervision of all sponsor and/or FDA site audits

Qualification:

Bachelor or Master degree in Health care (Pharmacy, biology, public health) related field.

At least 3 years of experience in clinical quality field.

Job Types: Full-time, Contract

Pay: $55,000.00 – $66,000.00 per year

Schedule:

* Monday to Friday

Experience:

* HEDIS: 1 year (Preferred)

License/Certification:

* Epic Certification (Preferred)

Ability to Commute:

* Bridgewater, NJ (Required)

Ability to Relocate:

* Bridgewater, NJ: Relocate before starting work (Required)

Work Location: In person