Risk Manager at Worldwide Clinical Trials

Remote
Worldwide Clinical Trials

Risk Manager – US (Remote)

Vacancy No: VN2529

Employment Type: Regular

Location Country: United States

Location City: Morrisville

Detailed Description

SUMMARY

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. Will assist in the maintenance of the risk library and provide guidance to ensure consistency within programs, therapeutic areas and/or sponsors.

RESPONSIBILITIES:
Some team members may focus on a limited number of these responsibilities depending on requirements. Tasks may include but are not limited to:

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.
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

  • 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

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needs

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