Sr. Clinical Compliance Manager

Medical Health Sciences Parsippany, NJ


Description

 

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Job Title: Senior Clinical Compliance ManagerSalary Grade:9

Department: Clinical/300FLSA Status:Exempt

Reports to: Associate Director, Clinical Operations Prepared Date:Apr2022

 

Summary:

The Sr. Clinical Compliance Manager is responsible for monitoring compliance and process efficiency of clinical trials run by Pacira using a quality by design approach. This individual will work directly with clinical operations team, clinical sites and Pacira Quality to reinforce GCP and regulatory compliance, facilitate audit responses, improve processes and enable constant inspection readiness.

 

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.  Other duties may be assigned.

  • Work with functional areas to measure and analyze compliance and efficiency of the clinical processes, implement improvement plans and monitor the performance
  • Perform initial and ongoing risk assessments with the clinical operations team members, monitor compliance and performance, as well as propose mitigation plans for the identified risks
  • Monitor the compliance/quality/performance of the following critical aspects of a clinical trial
    • Verifying documentation that all personnel have the education, experience and training to perform their assigned tasks
    • Verifying documentation of all processes used in the conduct of the clinical trial(s) including vendors’ processes
    • 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 to monitor vendors’ performance
    • 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.
    • In collaboration with Clinical Operations and Quality, verify the quality and associated documentation of clinical monitoring, medical monitoring, safety oversight and data quality, by reviewing reports, documents, site metrics, and plans to verify ALCOA and working with the team to address any concerns or discrepancies.
    • Perform QC of clinical documents including protocols, clinical study reports, Investigator Brochures, etc.
    • Facilitate the quality, completeness, timeliness and metrics of study TMFs and other study documentation management systems; this includes TMF audits and remediation efforts for all clinical studies
    • Develop, author, revise and/or implement Standard Operating Procedures (SOPs)
    • In collaboration with Clinical Quality Assurance, provide direct support for internal process improvement initiatives, such as, Inspection Readiness activities (e.g., Mock Inspection, Mock Inspection Interviews, Gap Assessment) and other initiatives involving Clinical Operations
    • Other duties as assigned by manager

 

Supervisory Responsibilities:

None

 

Interaction:

This clinical incumbent will work closely with Clinical Operations, Clinical Quality Assurance, Medical, Data Management, Statistics, Regulatory Affairs, Pharmacovigilance, as well as external consultants, clinical research organizations (CROs), vendors, and clinical site personnel.

 

Education and Experience:

  • Bachelor’s degree, or equivalent, in Science related discipline preferred. 
  • At least 5 years of experience working in a Clinical Operations environment is required; pharmaceutical industry or CRO experience is required; experience in the areas of clinical site monitoring and TMF maintenance is required; experience in Quality Assurance is preferred.
  • Global Clinical Operations experience is essential.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Knowledge, Skills, and Abilities:

  • Demonstrated knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with medical terminology is necessary.
  • Proficiency using Microsoft Outlook, Word, Excel and PowerPoint.
  • Excellent oral and written English communication skills.
  • Experience in various electronic data capture systems (EDC), electronic trial master file (eTMF), and clinical trial management systems (CTMS).
  • Working knowledge of FDA regulations and ICH/GCP.
  • Ability to manage and prioritize workload effectively.
  • Ability to operate remotely, but with availability to travel extensively and on short notice and manage travel schedules (up to 50%).

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 

This is a fully remote role.

 

Signatures:

 

Employee:                                                                                                 Date:                                

 

 

Supervisor:                                                                                                Date:                               

 

 

Human Resources:                                                                                    Date:                                

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