Risk Manager – Clinical Research

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🔥 9 minutes ago

🇧🇬 Bulgaria – 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.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 and mitigate risks associated with complex indications • Coordinate with the central monitor team and verify work when required • 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 functional plans to mitigate risks effectively • Use tools for remote data reviews and centralized statistical monitoring to identify risks to data quality and integrity • Facilitate internal and sponsor reviews of findings and obtain cross-functional support for complex risks and mitigations • Deliver initial and ongoing training to study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies • Escalate risks or at-risk deliverables, including scope changes, to the Project Manager • Provide strategic input on risk characterization and reporting to leadership • Assume additional responsibilities as required when appropriately qualified and trained

🎯 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, 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 (sorting, filtering, 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 (excellent oral and written) • Ability to communicate clearly and effectively at all levels within the organization and with external customers • Fast learner able to understand new concepts quickly • Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands • Excellent understanding of project protocol and project documentation, including centralized monitoring and risk-based monitoring • Broad working knowledge of the roles, functions and process of conducting clinical trials • Ability to manage time effectively while working with multiple functions and requirements • Involvement in the use of trial management or data management systems • Good knowledge of good clinical practices and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines • Must be legally able to work in Bulgaria

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Ongoing learning and development • Attractive advancement opportunities • Stimulating work environment

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