Added - 05/21/21 Regulatory Project Manager Research | Direct Hire

3 weeks ago


New Haven, United States Walt Medina & Associates, LLC Full time

Added - 05/21/21

Regulatory Project Manager

Research

Direct Hire Our Client Seeks: REGULATORY PROJECT MANAGER Title:

Regulatory Project Manager Reports to:

Senior Project Manager Job Summary:

Reporting to the Senior Regulatory Project Manager, the Regulatory Manager is tasked with maintaining quality control functions and monitoring compliance for research studies supported by the regulatory affairs department and involved with proactively addressing issues to ensure overall integrity in document management through quality and compliance checks. Working collaboratively with key stakeholders within Cancer Center Clinical Trials Office (CTO), as well as colleagues across the Cancer Center research enterprise, this role will oversee assigned service lines (workflow processes) and track regulatory activation milestones and timelines, promoting timely and compliant opening of new studies, in addition to providing administrative oversight of clinical trials by actively monitoring approvals, document creation, sponsor relationships, and overall study management from a regulatory perspective. Supervise day-to-day work activities of assigned regulatory staff, including delegation of work units and managing staff workload through communication of job expectations, planning, monitoring, and evaluation of work product. Provide quality reviews and oversight functions for all institutional review board (IRB) submissions and post-approvals to ensure regulatory integrity, while evaluating submission metrics and staff feedback to identify gaps in efficiency. Manage regulatory compliance activities related to quality control, including audit preparation, responses related to regulatory findings, reportable events, corrective actions, and other special projects related to efficiency and compliance within the regulatory department. Job Requirements: Minimum BA/BS Degree or equivalent (

Master’s highly preferred

) 5-years of direct regulatory experience / 3-years of regulatory supervisory experience Strong knowledge of FDA Regs., Good Clinical Practice guidelines and applicable federal regulations Knowledge of National Cancer Institute Cancer Center Support Grant preferred Compensation: Offering a highly “

competitive base salary ”

(

commensurate with experience

), excellent company benefits package, PTO, pension plans, relocation assistance and much more… FOR MORE INFORMATION CONTACT: WALT MEDINA CPC Consultant / Executive Search Services / Healthcare Practice

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