Risk Manager (Remote/Latin America) -Sign-on Bonus

Multiple Locations: Morrisville, NC, USA • North Carolina, USA • Argentina • Colombia • Mexico • Chile • Brazil

Notice

This position is no longer open.

Requisition Number: 3084

Position Title: Risk Manager

External Description:

The Centralized Data Review team at Worldwide Clinical Trials is hiring a Risk Manager to be home-based (remote) in Latin America.

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, centralized monitoring, and the wider monitoring strategy.
    Drafts initial risk assessment and supports the project team in finalizing 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 a study level review of KRIs/KPIs or statistical monitoring.
  • With the 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 mitigate potential threats to the successful conduct of 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 of 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 a global environment

#LI-HD1

City:

State:

Employment Type: Regular

Community / Marketing Title: Risk Manager (Remote/Latin America) -Sign-on Bonus

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park (RTP), North Carolina US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.

 Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendors

© Worldwide Clinical Trials 2023

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.