Risk Manager (Remote/EU)

Employer
Worldwide Clinical Trials
Location
HOMEWORKING, Nottingham, GB
Salary
Competitive
Closing date
11 Oct 2020

View more

Discipline
Operations
Hours
Full Time
Contract Type
Permanent
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The Centralized Data Review team at Worldwide Clinical Trials is hiring a Risk Manager to be home-based (remote) in Europe.

Role: The Risk Manager will coordinate cross-functional risk management and central monitoring activities for assigned clinical trials in accordance with monitoring in accordance with ICH GCP E6 requirements. He/she will assist in the maintenance of the risk library and provide guidance to ensure consistency within programs, therapeutic areas and/or sponsors.

Responsibilities: Serves as the Risk Management Lead within the assigned project team:
  • Understands the study scope of work, budget and protocol content for their assigned trial.
  • Provides subject matter expertise for the development and maintenance of the monitoring strategy required for the trial.
  • As required, develops and delivers training to the study team regarding the risk assessment, centralised monitoring and the wider monitoring strategy.
    Drafts initial risk assessment and supports the project team in finalising the Risk Planning Tool, ensuring cross functional involvement.
  • Develops the RMP for the assigned study and gains GPL and Sponsor approval. May provide advice on the development of functional plans.
  • Supports the GPL in ensuring compliance with cross-functional review of risks throughout the trial.
  • Ensures Inspection Readiness for risk assessment and centralised monitoring scope.
  • Maintains the Risk Library.
  • When required, will conduct study level review of KRIs/KPIs or statistical monitoring.
  • With support and where required, collaborates with other team members and Sponsor to identify and track trial level Quality Tolerance Limits.

Skills and Attributes:
  • Excellent communication, presentation and interpersonal skills.
  • Excellent planning and organizational skills with effective time management
  • Excellent interpersonal skills
  • Knowledge of clinical project financial principles
  • Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identify and mitigating potential threats to the successful conduct a clinical research project.
  • Ability to lead and motivate assigned team (if applicable)
  • Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
  • Proficiency in Microsoft Office

Requirements:
  • BSc/RN or equivalent combination of knowledge, skills and experience
  • At least 8 years knowledge and prior experience of Risk Based Monitoring and associated ICH/Regulatory guidance required. Experience as a Risk Manager, preferred.
  • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
  • Demonstrated ability to lead and align teams in the achievement of project milestones, as well as demonstrated capability of working in global environment

#LI-HD1

Are You Seeking A Career With Purpose?

The time is right to join our growing team, consisting of 1,600 talented and dedicated employees from across the globe. We’re doing innovative and exceptional work each and every day. Our team is filled with purpose, as we support our sponsors in the discovery of cures and treatments for diseases affecting millions of people around the world.

If you’re looking to join an energetic and collaborative team that is valued and supported by company leadership, committed to operational excellence and open to creativity and innovation, Worldwide Clinical Trials could be the ideal place for you. We have exciting opportunities in clinical drug development, project management, corporate functions, sales, and more. Explore current openings and learn more about Worldwide’s culture below.

What We Believe

At Worldwide we operate under a shared mission, vision and set of cultural values. But these aren’t just words on a page. They are a daily inspiration and a shared commitment. Because we know that when we work towards a common goal and when we bring our best selves to the job every day we can climb mountains for our customers!

Contact Us
  • 2nd Floor
  • 172 Tottenham Court Road
  • W1T 7NS
  • GB
  • 0207 121 61 61
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