Clinical Compliance Manager

Location: Parsippany-Troy Hills, New Jersey, USA
Salary: US$65 - US$69 per hour + optional benefits package
Job Type: Contract
Apply for this Job

Clinical Compliance Manager

Duration: 6-month contract to FTE

Location: Parsippany, New Jersey

Compensation: $65-69 per hour

The Clinical Compliance Manager will be responsible for a lead role in the design and development of Clinical policies and procedures including but not limited to SOPs and associated forms and templates. 2) Verify documentation that all personnel have the education, experience and training to perform their assigned task(s). 3) Participate on the vendor selection, qualification and governance teams, reviewing their processes, identifying possible risks, determining mitigation plans, defining quality/compliance/performance metrics and Key Performance Metrics. 4) Manage non-compliance issues (audit findings, deviations, quality issues) by defining the compliance issue, facilitating the investigation and root cause analysis, proposed corrective and preventive actions, and overseeing the implementation of the CAPA and effectiveness checks as needed. 5) Collaborate with Clinical Operations, monitor the quality, completeness, timeliness and metrics of the eTMF and other study documentation management systems.

Requirements

  • Education: Bachelor's degree, or equivalent, in Science related discipline preferred; Post graduate qualifications in scientific or business-related field preferable.
  • At least 5 years of closely related health sciences experience working in a Clinical Operations environment is required; pharmaceutical industry experience is preferred; experience in the areas of clinical site monitoring.
  • Global Clinical Operations experience is essential.
  • Proficiency using Microsoft Outlook, Word, Excel and PowerPoint
  • Must have experience in various electronic data capture systems (EDC), electronic trial master file (eTMF), and clinical trial management systems (CTMS), QA document management system (DMS).
  • Experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions (CAPAs).

Sthree US is acting as an Employment Business in relation to this vacancy.

Apply for this Job