Europe

Date:

August 10, 2010

Title:

Clinical Quality Manager

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Chertsey, UK

Experience Required:

10 years BioPharma R&D

Education Level:

Bachelor's degree, science related field

Role Purpose/Position Overview

• To lead and manage department Inspection Readiness for Clinical departments.
• To manage and maintain metrics on department adherence to regulatory requirements and department standards to ensure department quality.
• To develop and oversee a Quality Management Plans (QMP) for clinical functions.
• To conduct Quality Control Visits to determine compliance with SOPs, ICH/GCP, applicable regulations, and study protocol.
• Provide feedback on findings with critical attention to addressing issues with solution-oriented proposals

Key Accountabilities/Responsibilities

• Develop and manage a Clinical department Inspection Readiness Plan
• Develop, implement and monitor adherence to clinical department QMPs including the quality oversight of vendors and contractors assigned to clinical oversight of studies
• Define, develop, implement and continually improve quality control measures within the Monitoring Program, including a list of standard quality checks to be performed as part of the Performance Assessment Visits (PAVs) and Quality Control (QC) visits
• Develop and maintain guidelines for the conduct of Performance Assessment Visits (PAVs) and Quality Control (QC) Monitoring Visits to assess study conduct and overall site performance
• Collect and analyze qualitative and quantitative results from PAVs and QC visits and report results to management team
• Conduct periodic QC monitoring visits with a sample of sites and monitors and liaise with management on project compliance concerns or trends
• Interact with CRA Managers to determine a plan for PAVs for each monitor on a routine or as needed basis
• Provide and support to CRA Managers in conducting PAVs according to plan
• Develop a tracking system to ensure regular PAVs are done for all monitors
• Communicate concerns or progress and resolution of issues resulting from PAVs and QC visits to appropriate clinical staff
• Work with CRA Managers and Monitors to address concerns and resolve issues through on-site assessment and training when potential compliance issues are identified
• Conduct QC assessments to verify selected study documents are complete and correct
• Provide on-site training for monitoring staff as needed
• Collaborate with Clinical Training and Standards in the development and presentation of continuing education sessions based on QC visit and PAV findings
• Develop reports for management to highlight concerns and action plans
• Collaborate with GCP Compliance/QA to identify trends from GCP Compliance/ QA site audits and make recommendations to management to improve overall findings
• Identify need and assist with implementation of process and efficiency improvement
• Support clinical team in preparing for external audits.
• Support clinical team by providing input into the generation of timely and appropriate audit responses
• Provide staff support by answering questions or providing advice on ICH, GCP, SOPs, local regulations and guidelines
• Maintain strong working knowledge of SOPs as well as ICH, GCP, local regulations and guidelines

All other duties as required

Requirements

• Ten years in biopharmaceutical research & development or CRO
• Eight years as a CRA and/or Clinical Manager in the biopharmaceutical industry preferred.
• Four years experience in a staff leadership role.
• Experience with developing SOPs and department processes.
• Experience with quality assurance audits preferred.
• Experience with training and mentoring clinical research staff.

Previous experience using computer software including Microsoft Office products and e-mail.  EDC and CTMS experience desirable.

• Strong interpersonal and written/oral communication skills to facilitate interaction with internal and external customers
• Solid understanding of the clinical research process, regulations pertaining to good clinical practice, and the function of quality control in the conduct of clinical studies
• The ability to work independently with occasional oversight
• Team oriented attitude
• The ability to work effectively and diplomatically with supervisors, peers, and support personnel both internal and external to the organization.
• Strong time management and organizational skills
• Attention to detail and accuracy in work
• Ability to multitask and prioritize in a rapidly moving environment
• Ability to lead teams and projects in a matrix environment
• Expert in the requirements and interpretation of Clinical SOP’s.

 A strong working knowledge of US FDA, EU and GCP and local regulations is required.  Must be detail oriented, self motivated, organized and have the ability to prioritize work. Additionally, must be able to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situation and deadlines. 

 Must be able to travel without restriction. Office-based environment on non-travel days, requires ability to sit for long periods of time operating computer/telephone

Please apply with cv to: 

CQM060810@unither.com

EOE