Clinical Study Quality Manager

Job type:
on-site
Start:
ASAP
Duration:
6 months
From:
Harvey Nash IT Recruitment Belgium
Place:
Brussel
Date:
05/14/2013
Country:
flag_no Belgium
project ID:
535795

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A multinational company in the pharmaceutical industry is currently looking for a Clinical Study Quality Manager.

Location: Walloon Brabant
Duration: 6 months

Scope of work:
The Clinical Study Manager oversight role is being responsible for developing processes and activities to get a better control on Quality of our clinical studies and deliverables and guarantee adequate monitoring oversight of clinical studies, according to international conference on harmonization(ICH) with Good Clinical Practice (GCP)guidelines, company policies, Standard operation procedure (SOP) and quality standards.

The Clinical Study Quality Manager will:
Liaise the different level of the organization and help collaboration and process respect

Facilitate Study Risk Assessment exercise including:
o local operation company (LOC)
o Clinical research organization (CRO)

Liaise and collaborate with Process Improvement team to:
o improve processes
o develop new processes
Liaise with Quality function to:
o make sure quality issues are followed-up
o action plan are implemented
Contribute to functional risk registers exercise
Strengthen and formalize the escalation process
Ensure appropriate documentation and training material:
Guarantee appropriate documentation of study oversight
eg review a proportion of documents, provide qualitative feedback to author/manager,
Ensure training material is developed and provided for all functions working on the study
review the protocol deviations and ensure action plan if needed

Help with support and advice for inspection:
Participate to Inspection Readiness of Central teams
Provide support for Mock Inspection
Support team members when defining corrective/preventive actions following
audit/inspection

Collaborate, ensure and challenge planning:
Cooperate on the elaboration of the yearly planning for site assessments (L2)
Work on quality and consistency of process
Review key documents (eg concept protocol, protocol, ICF, ) for the quality aspects and
consistency (QC check)
Develop, review and analyse the Key Risk Indicators and monitoring metrics and ensure
action plan if needed
Develop and promote a "right first time" quality mind-set among teams
Ensure Quality Control on monitoring is done/documented and participate in developing
corrective plans if needed

Requirements:
Education: Master degree in Sciences
Fluent French and English
Good communication and adaptability skills
Able to positively communicate more effective ways of working
Encouraging others to adopt and become champions of oversight
Quality mindset, critical sense, attention to details
Manages change positively, and sees change as an opportunity to improve quality
Promotes a total quality culture
Risk assessment minded, ability to anticipate problems and help teams to build appropriate
mitigation plan.
Curiosity
Enterprise thinking
Team spirit
Global Study Management roles and activities
ICH-GCP (+) accreditation
Proficient in audit processes, including consultation on audit-related activities
4 years as CRA (Clinical Research Associate) and 6 years in clinical research function
Monitoring experience
Any previous experience in a quality function is a plus

Keywords: CRA, CRO, clinical trial, clinical study, quality, QA, quality assurance; GCP, ICH