Risk Manager (US/Remote)
Location: North Carolina, United States
Requisition Number: 1914
Position Title: Risk Manager
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. Will assist in the maintenance of the risk library and provide guidance to ensure consistency within programs, therapeutic areas and/or sponsors.
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 centralized 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.
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
- 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
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Risk Manager (US/Remote)
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, North Carolina US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.