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TMF Quality and Process Compliance Manager

Posted on Feb 7, 2020 by Harvey Nash IT Recruitment Switzerland

Basel, Switzerland
Health Care
Immediate Start
Annual Salary
Contract/Project

For our client in Basel we are looking for TMF Quality and Process Compliance Manager for a 1 year project.

Description:

Job Title: TMF Quality and Process Compliance Manager
Duration: 01/03/2020 to 28/02/2021

Location: Basel

Workload: 100%

Job Purpose
. Responsible for monitoring of TMF process compliance using metrics, while ensuring optimal functioning of TMF processes and systems to support business deliverables and meet Health Authority requirements

Major Activities
. Core member of the TMF Operational Excellence team, responsible for monitoring overall compliance with TMF processes using functional metrics related to TMF
o In collaboration with line functions and the TMF Governance and Management team develop KPIs/KQIs to measure quality and completeness of TMFs
o Conduct periodic evaluation of the KPIs/KQIs and reporting capabilities
o Track progress to KPIs/KQIs, and overall compliance to TMF processes
o Identify and escalate trends/metrics to CDGM representatives to develop remedial actions. Support root cause analysis (eg re-training, process change, system/tool enhancement etc..)
o Support compliance and overview of mandatory TMF training
. Proactively partner and successfully collaborate with key stakeholders across and support TMF user community to achieve KPIs/KQIs related to the TMF
. Support 100% inspection readiness at all times by contributing to the overall inspection readiness strategy and proper planning of TMF self-assessment and periodic reviews in close collaboration with the TMF Governance and Management team
. Track recent TMF audit and inspection findings to ensure proper oversight by CDGM across the portfolio. Contribute to the identification of lessons learned from audits and inspections. Collaborate with the TMF Operational Excellence Communication and Training managers to share learnings from TMF related audit and inspection findings with the TMF user community
. Promote best documentation practice to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and SOPs
. As a TMF Operational Excellence representative, may participate in global cross-functional business process performance or clinical development improvement initiatives

Ideal Background

Education:
. Bachelor's degree in life science/healthcare is required with 3-5 years of experience in clinical development with a minimum of 2 years in global clinical research/clinical operations and/or clinical systems management

Languages:
. Fluent English (oral and written)

Experience/Professional requirement:
. Advanced ability to work both independently and in a global cross-functional multicultural and international team
. Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice. Experience in these areas is preferred
. Excellent understanding of system data structures and Clinical Document Management System functionality
. Excellent attention to accuracy and detail
. Excellent communication, organization and tracking skills
. Strong operational skills and demonstrated ability to meet timelines
. Proven networking skills and ability to train colleagues

For further details please contact Dagmara Filipowicz:

Phone Number/E-mail: (see below)

Reference: 840689315

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