Senior Central Risk Manager – Sponsor Dedicated

🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🎲 Risk

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.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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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide advice and subject matter expertise for developing project monitoring strategies • Advise project teams on monitoring strategy updates based on risks • Work with cross-functional leads to understand complex indications and risks and identify mitigations • Provide guidance to ensure consistency within programs, therapeutic areas and sponsors • Draft initial risk assessments and support finalization of the Risk Assessment Categorization Tool (RACT) • Ensure identified risks are transferred to the correct tracking system • Support ongoing cross-functional review of project risks • Advise on functional plans to mitigate identified risks • Assess tools for remote data review and centralized statistical monitoring • Identify risks to data quality and integrity • Facilitate review of findings with internal cross-functional teams and sponsors • Collaborate to identify Quality Tolerance Limits • Develop and deliver initial and ongoing training on risk assessment, centralized monitoring and risk-based monitoring strategy • Coach and mentor peers on functional delivery, project risk evaluation and action implementation • Collaborate with functional areas to ensure compliance and delivery according to protocol, ICH/GCP, GPP and country regulations • Ensure inspection readiness for risk assessment and centralized monitoring scope • Understand study scope of work, budget and protocol content • Escalate at-risk deliverables, out-of-scope activities and requests to the Project Manager • Participate in business development, including monitoring strategy and budget input, meeting definition and proposal development

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Master's degree or health data sciences degree preferred • Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements • Expert in Risk-Based Monitoring Strategies processes and tools preferred • Expert in Integrated Quality Risk Management (IQRM) theories • Good computer skills and ability to embrace new technologies • Mastery of MS Excel, including sorting, filtering, calculating and pivoting • Mastery of analytical data visualization tools • Knowledge of statistical analysis techniques, visualizations and tools, including Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, and Box and Whiskers • Knowledge of Lean Six Sigma and RACT tools • Strong analytical skills and well-developed understanding of statistical concepts • Well-developed therapeutic expertise • Excellent verbal and written communication skills • Strong negotiation, organizational and problem-solving skills • Strong leadership, tactical and strategic thinking skills • Ability to anticipate and address critical issues and develop contingency plans proactively • Knowledge of financial concepts related to forecasting, budgeting and proposal generation • Understanding of workflow processes, roles and responsibilities across multiple functional areas • Ability to understand, explain and communicate project concepts and put them into detailed plans • Ability to teach, train and mentor employees of all levels

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Opportunities for specialized therapeutic or functional team collaboration • Diverse career paths and employment opportunities