Central Risk Manager – Risk Based Central Monitoring

🔥 15 hours ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 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

• Advise on development and updates to project monitoring strategies based on risks • Work with cross-functional leads to understand complex indications and risks and identify mitigations • Draft initial risk assessments and support finalization of the RACT • Ensure identified risks are transferred to the correct tracking system and support ongoing cross-functional review • 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 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 across functions to ensure compliance with protocol, ICH/GCP, GPP and country regulations • Ensure inspection readiness for risk assessment and centralized monitoring • Understand assigned study scope of work, budget and protocol • Escalate at-risk deliverables and out-of-scope activities to the Project Manager • Participate in business development, monitoring strategy, budgeting, meetings 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 (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, problem-solving, 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

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture