Associate Director, Clinical Trial Management

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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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 leadership, direction and management to Clinical Trial Managers and Senior Clinical Trial Managers • Oversee monitoring and site management activities to ensure clinical deliverables are met • Act as primary point of contact for monitoring strategy and alignment internally and externally • Guide teams and sponsors in implementing efficient, high-quality risk-based monitoring solutions • Oversee critical data and process identification, risk assessment, risk tracking and mitigation strategies • Coordinate access to data required for risk-based monitoring • Provide operational oversight, prioritize activities, monitor work and metrics compliance, and develop contingency plans • Analyze performance and quality metrics related to patient safety, data integrity and risk-based monitoring success • Escalate and manage clinical, central monitoring, risk-based monitoring and project risks and issues • Ensure team tasks meet sponsor expectations, contracts, regulations, SOPs/WIs and ICH GCP requirements • Develop customer relationships, manage expectations and escalate serious risks and issues • Identify process improvements and efficiencies • Participate in committees, work groups, marketing activities, client presentations and proposal development • Support Business Development during bid defense and proposal processes • Provide line management, administrative oversight, professional development, performance appraisals and mentoring • Set staff goals, delegate tasks, review workload, utilization, productivity and quality • Manage resource availability, resolve resourcing conflicts and support hiring and staff growth • Promote staff retention and ensure required training and documentation • Provide compliance updates to management • Participate in clinical trial management delivery audits and prepare others for audits

🎯 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 • Familiar with Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements • Familiar with Risk-Based Monitoring Strategies processes and tools preferred • Familiar with project risk and issues management • Experience interacting with sponsors, including experience handling conflict and difficult conversations • Ability to persuade and influence both above and below as well as internal and external • Experience in operational efficiency and using data and metrics to drive performance and decisions • Good computer skills and ability to embrace new technologies • Mastery of MS Excel (sorting, filtering, calculating, pivoting) • Familiar with 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 • Familiar with financial concepts related to forecasting, budgeting, and proposal generation • Familiar with management of utilization, resources, hiring targets and productivity metrics • Understanding of workflow processes, roles and responsibilities across multiple functional areas • Ability to teach, train and mentor employees at all levels • Above-average attention to detail, accuracy, organizational, interpersonal and team-oriented skills • Comfortable making tough decisions and communicating decisions and rationale internally and externally • Less than 30% travel may be required

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Company car or car allowance may be available • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time