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 to propose mitigation plans for the identified risks
Take a lead role in the design and development of Clinical policies and procedures including but not limited to SOPs and associated forms and templates. Works closely with Clinical Management, SMEs and other functions as applicable to develop and update clinical processes as needed. Works with a change control document management system.
Monitor the compliance/quality/performance of the following critical aspects of a clinical trial
Verify documentation that all personnel have the education, experience and training to perform their assigned tasks
Verify 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, verify the quality 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.
In collaboration with Clinical Operations, monitor the quality, completeness, timeliness and metrics of the eTMF and other study documentation management systems
Support conduct of inspections and audits and closely collaborate with the CQA audit department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents; assigning roles and responsibilities for each audit/inspection.
Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses and resulting measures.
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), QA document management system (DMS).
Good understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.
Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
Experience working within a change control process and document management system.
Working knowledge of FDA regulations and ICH/GCP.
Source: Job Diva – Job Listing