Overview

Reference Number: JO-2111-479396
Clinical Compliance Manager
Rate: Negotiable
Job Type: Permanent
Location: City

We have a new role with our client specialising within clinical research, looking after compliance within the quality department.

Key Responsibilities:

Develop and implement a quality policy, defining and mapping quality processes

Implement a process for identifying quality needs plus developing/modifying SOPs, policies and guidance to address any gaps

Performing quality checks on all aspects of the clinical research activities performed within company and ensuring appropriate document management and control.

Investigating and classifying reported Quality Issues.

Facilitation of root cause analysis sessions within study teams.

Developing and implementing corrective and preventative action plans in conjunction within study teams.

Providing guidance to study teams on operational quality, risk and regulatory and legislative compliance

Providing support to external client audits and regulatory inspections.

Revising procedures, reports etc, periodically to identify hidden risks or non-conformity issues

Assessing the businesss future ventures to identify possible compliance risks

Keeping abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control

Preparing reports for senior management and external regulatory bodies as appropriate

Supporting staff training and engagement in company Quality Management System

Desired Skills and Experience:

At least 4 to 5 years experience in a similar role

Excellent GCP guidelines and quality regulations/expectations pertaining to clinical trials.

Knowledge of maintaining and improving quality systems and procedures.

Prior experience in a Quality role with knowledge of performing Quality checks or audits of data.

Exposure to client audits and regulatory inspections, ideally in a Quality role.

A demonstrated commitment to quality in a regulated environment.

Ability to work independently

Exceptional customer services skills to both internal and external stakeholders.

Proven clinical trials project management

Life science or other relevant degree

Please contact sheldon.grant@cpl.com for more info

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