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Senior Clinical Risk Manager

Posted on Feb 28, 2020 by Harvey Nash IT Recruitment Switzerland

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

For our client in Basel we are searching for Senior Clinical Risk Manager for 1-year project

Job Title: Senior Clinical Risk Manager
Duration: ASAP for 12 months
Location: Basel

Workload: 100%

Job Purpose

The Senior Clinical Risk Manager supports the pro-active and continuous improvement of quality, data integrity and general regulatory/ICH-GCP requirements across Global Development Operations (GDO). The Senior Clinical Risk Manager is responsible to support the identification and mitigation of relevant cross-functional, systemic risk and issue trends as well as track high-level the status of the investigation and remediation progress of high-impact, functional, systemic risk and issue trends.

He/she is responsible to analyse available data sources for cross-functional, systemic issue and risk trends and to perform, or lead cross-functional teams to perform, data-driven and thorough root cause analyses followed by leading subsequent remediation activities (workstreams, initiatives, etc).

Major Activities

  • Supports the establishment and strategic development of the clinical risk management group in the GDO Risk Management Office
  • Supports the development of appropriate tools, frameworks and governance platforms that support collaboration amongst, and risk and issues trending and reporting by the RMO and the functional quality and compliance related groups in GDO (eg PCM groups)
  • Contributes to the development and maintenance of a standard business process across GDO that aims at triaging and reporting of systemic quality issues and risks to the appropriate escalation and decision level. May act as owner of that process
  • Contributes to the development and maintenance of an appropriate issue and risk registry for systemic quality risk and issue trends across GDO. May act as owner of the registry and/or relevant content
  • Identifies data sources for trending for cross-functional, systemic risks and issues and finds opportunities and methodologies how to access and investigate that data. Screens data for possible trends to identify areas that pose a quality risk to future portfolio activities if not mitigated
  • Analyses available data sources on potential, GDO-relevant, cross-functional, systemic quality risk and issue trends and performs a risk assessment considering at minimum frequency/likelihood of repeat occurrences and degree of impact. Brings results forward to GDO QRB to agree on route of action
  • Where the need for remediation is confirmed by GDO QRB, performs a data-driven root cause analysis to identify which areas in particular need to be improved to avoid repetition of cross-functional, systemic quality issues moving forward. Leads cross-functional teams in data-driven root cause analyses where the need for such a team is identified
  • Upon identification of key root causes of cross-functional, systemic risks and issues, leads cross-functional teams in identifying, planning and implementing appropriate mitigation plans. Ensures that improvements are measurable and that effectiveness checks will be in place
  • Aligns with the process excellence groups across GDO and beyond (eg GDD, NIBR, GMA) to ensure that any function-specific risk and issue trends that were incidentally identified while reviewing and scouting data have been or will be picked up by the respective functional group for further analysis and mitigation
  • Tracks progress of mitigation plans and their implementation for cross-functional risks as well as high-impact functional risks. Tracks whether improvement targets are met and where not raises it for further action
  • May lead the development/enhancement of GDO-wide key risk/quality
  • May lead the development of feedback loops with GDO associates on identified systemic issues, risks and planned mitigations to enable them to plan these into their own project plans

Ideal Background

Education (minimum/desirable):

  • Bachelor degree in life science, quantitative science or business

Languages:

  • Fluent in English (oral & written)

Experience/Professional requirement:

  • 5+ years of experience in clinical operations
  • 3+ years of experience in a risk management, quality management, process improvement or related role
  • Thorough understanding of the drug development process and ICH-GCP requirements
  • Experience with data mining/analysis, basic statistical methodologies as well as root cause analyses
  • Ability to think independently and out of the box and able to assess and resolve complex problems
  • Excellent project management skills with track record of leading projects to successful conclusion
  • Proficient communication, influencing, negotiating skills
  • Proven ability to work independently in a complex Matrix environment (incl. remote or virtual team environment)
  • Experience in developing effective working relationships with internal and external stakeholders
  • Organizational awareness, including experience working cross-functionally and in global teams

For further details please contact Aleksandra Kalicka:

e-mail: (see below)

Reference: 851946428

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