
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.
🕒 September 2
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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.
• Advise on development and updates to project monitoring strategies based on risks • Work with cross-functional leads to understand complex indications and risks and develop risk mitigations • Draft initial risk assessments and support finalization of RACTs • Transfer identified risks to the correct tracking system and support ongoing cross-functional risk reviews • Advise on functional plans to mitigate identified risks • Assess tools for remote data review and centralized statistical monitoring, identifying data quality and integrity risks • Facilitate review of findings with internal cross-functional teams and sponsors • Collaborate to identify Quality Tolerance Limits • Develop and deliver training on risk assessment, centralized monitoring, and risk-based monitoring strategies • Coach and mentor peers on functional delivery, project risk evaluation, and action implementation • Collaborate across functions to ensure compliance with protocols, 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 and out-of-scope activities to the Project Manager • Participate in business development, including monitoring strategy, budget input, meetings, and proposal development
• 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 (sorting, filtering, calculating, 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 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 create detailed plans • Ability to teach, train, and mentor employees at all levels • Above-average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills • Excellent written and spoken communication and presentation skills • Less than 30% travel required
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Flexible remote work arrangement (Remote (Pre-Approved))
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