Risk Manager – Clinical Research

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🔥 3 minutes ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 34 days.
• No salary listed.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Develop and update risk-based monitoring strategies tailored to project needs • Collaborate with cross-functional teams to identify, assess, and mitigate risks associated with complex indications throughout the clinical trial lifecycle • Coordinate with the central monitor team and verify work as needed • Provide budget recommendations and change orders • Draft initial risk assessments and support finalization of Risk Assessment and Categorization Tools (RACT) • Guide Project Managers in transferring identified risks to appropriate tracking systems and ensure ongoing reviews • Advise on developing functional plans to mitigate risks • Conduct remote data reviews and centralized statistical monitoring to identify risks to data quality and integrity • Facilitate internal and sponsor reviews of findings, obtaining cross-functional support for complex risks and mitigations • Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies • Escalate risks, at-risk deliverables, and scope changes to the Project Manager • Provide strategic input on risk characterization and reporting to leadership • Undertake additional responsibilities aligned with qualifications and training

🎯 Requirements

• Bachelor’s degree in a field relevant to clinical research • Experience in a CRO or pharma industry • Minimum of 3 years in risk management within a clinical research setting • Minimum 5 years of experience across clinical monitoring, data management, and drug safety • Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements • Proficiency in Risk-Based Monitoring strategies, processes, and tools • Mastery of MS Excel, including sorting, filtering, and pivot tables • Advanced skills in analytical data visualization tools • Knowledge of Lean Six Sigma and web based RACT tools • Strong analytical and statistical understanding • Excellent communication, negotiation, and leadership skills • Ability to anticipate critical issues and develop proactive contingency plans • Skilled in project workflows and cross-functional collaboration • Training, mentoring, and organizational capabilities • High level of autonomy • Fluent in English, with excellent oral and written skills • Ability to communicate clearly and effectively at all organizational levels and with external customers • Fast learner able to understand new concepts quickly • Prioritization skills and ability to plan, monitor, and manage workload in response to changing project demands • Excellent understanding of project protocols and documentation, including centralized monitoring and risk-based monitoring • Broad working knowledge of clinical trial roles, functions, and processes • Effective time management while working with multiple functions and requirements • Experience using trial management or data management systems • Good knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines • Legally authorized to work in South Africa

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities • Reasonable accommodations throughout the recruitment and selection process for applicants with disabilities, upon request

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