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Ad Description: Clinical Quality Manager
(Singapore)



Responsibilities:


Integrate quality into the Covance business processes

Implementation of Global SOPs and coordinate local work instructions/SOP development/ updates to meet local needs

Coordinate GCP and SOP-related training within the Covance AP

Develop annual quality plan together with country/regional management

Perform targeted QC activities within the country offices

Prepare and report on quality metrics

Identify and communicate root causes of quality issues

Ensure management is aware of issues that will significantly impact clinical trials and recommend necessary activities and follow-up to resolution

Coordinate country/site audits by QA/Sponsor and facilitate audit follow-up

Conduct AFV (QC and/or Evaluation) at investigator sites (as per request from Country lead or regional management)

Effectively communicate quality control strategies, policies and procedures in conjunction with leadership teams

Develop and maintain effective relationships with management team to coordinate quality control activities in a matrix environment

Maintain good working relationships with internal and external clients to ensure opportunity to improve GCP and Quality for the operations
GCP and Quality Oversight:

Quality System, Quality Plan and Quality Report

Document the country quality system(s), ensuring clear accountabilities

Prepare the annual quality plan with the respective operational leads

Prepare quality reports at intervals determined by country and regional management e.g. prepare and submit monthly global Accompanied Field Visit (AFV) tracking report, prepare and submit monthly quality plan tracking report.
Qualifications and Training

Verify that curriculum vitae, job descriptions, curriculum maps and training records are adequate and appropriately filed quarterly.
SOPs / Work Instructions

Coordinate the review of global SOPs for adequacy and consistency with local regulations and provide feedback to Global SOP Group on new and updated global SOPs ("global review process")

Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff

Inform Clinical Team of new/updated global SOPS/local Work Instructions

Verify that SOP acknowledgments are documented

Identify gaps and overlaps in local Work Instructions

Verify that local Work Instructions are developed and that a historical file is maintained

Coordinate the review and approval of local SOPs, ensuring their timeliness
Training (in cooperation with training and development group and country/regional management)

Verify that a training matrix/plan is available and updated

Verify that training is coordinated and delivered

Assist to coordinate training when needed (as per request from management)

Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins
Quality Control of Key Targeted Clinical Trial Activities (in consultation with QA and operations)

Verify GCP/SOP implementation with a focus on the following key target areas:
informed consent, CT material study documentation (essential document filing & IP Package) monitoring AE reporting archiving

Conduct AFV (QC and/or Evaluation) at investigator sites (as per request from Country lead or regional management)

Identify and escalate GCP issues identified through regular interactions with clinical operation and project management personnel.
Ongoing Trend Analysis and Quality Improvement Initiatives

Analyze trends, identify areas of weakness and recommend actions

Coordinate quality improvement initiatives

Implement corrective changes

Escalate significant issues to management

Conduct "post-mortems"

Requirements:


University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) with minimum of two (2) years relevant clinical quality control or quality assurance experience required

Minimum of three (3) years supervisory experience in a health care or clinical research setting and

Minimum of six (6) years relevant clinical research experience in a pharmaceutical company/CRO

Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)

Thorough knowledge of drug development process

Thorough knowledge of relevant SOPs, ICH, and GCP guidelines

Project management, line management experience, and quality control experience highly desirable
Relevant quality management experience

Detailed knowledge about GCP guidelines and regulations

Demonstrated ability to separate critical from non-critical GCP issues

Demonstrated effectively balance quality and speed in complex situations

Demonstrated ability to work in a team environment

Demonstrated ability to work under pressure and requires minimal supervision

Strong interpersonal and communication skills

Strong analytical skills

Excellent planning and organizational skills

Excellent oral, written and presentation skills


Interested applicants please apply through www.covancecareers.com under Req #20645 or Email detailed CV & salary information to gynn.kok@covance.com.
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