Description
Syneos Health is seeking a Clinical Development Lead to provide leadership, direction, and management to Clinical Trial Managers. The successful candidate will oversee the quality related to monitoring and site management activities to ensure clinical deliverables are met. They will act as the primary point of contact for monitoring strategy and alignment both internally and externally for assigned studies.
Responsibilities:
- Provides expert monitoring strategy, oversight, and guidance to support internal teams and sponsors.
- Guides internal teams and sponsors through and documents the key decisions needed to implement a high-quality, efficient risk-based monitoring (RBM) solution.
- Oversees the identification of critical data and processes, the assessment of risks to protocol execution and clinical delivery, risk and issue tracking, and risk and issue mitigation strategies.
- Strategizes with internal team members and sponsors to agree on a "hybrid" approach that is efficient and effective when incorporating new data sources, technologies, or new/supplemental/substitute processes to support RBM.
- Works with internal team members and sponsors to ensure access to data needed to execute RBM according to the agreed plan.
- Provides operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans.
- Analyzes performance and quality metrics to assure business unit achievement of quality and compliance expectations related to patient safety and data integrity as well as RBM success measures.
- Functions as the point of escalation for clinical, central monitoring, RBM, and project risks and issues.
- Participates in work streams to support the development and implementation of new initiatives and strategic direction of the business unit, cross-business unit Clinical Operations, and cross-functionally.
- Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP.
- Oversees progress of teams supporting clinical projects.
- Ensures individual and team tasks are completed according to requirements per Sponsor/Customer expectations and contract.
- Develops and supports customer relationships, manages customer expectations, and escalates more serious risks and issues as required.
- Works closely within the appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors.
- Identifies needs and may make recommendations for process improvement and efficiencies.
- Participates in committees and work groups to support the development and implementation of new initiatives and strategic direction of the business unit and cross-business unit Clinical Operations.
- Provides support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required.
- Participates in marketing activities, client presentations, 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.
- 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.
- Must demonstrate good computer skills and be able 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.
- Knowledge of Lean Six Sigma, RACT tools.
- Strong analytical skills and well-developed understanding of statistical concepts.
- Well-developed therapeutic expertise.
- Excellent verbal and written communication skills.
- Strong negotiation skills, organizational skills, and problem-solving skills.
- Demonstrated strong leadership, tactical, and strategic thinking skills.
- Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.
- Familiar with financial concepts as related to forecasting, budgeting, and proposal generation.
- Familiar with management of utilization, resources, hiring targets, and productivity metrics.
- Demonstrate understanding of the workflow process, roles, and responsibilities of multiple functional areas, and ability to work across those functional areas.
- Ability to teach, train, and mentor employees of all levels to achieve project, departmental, personal, and organizational goals.
- Requires above-average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
Benefits:
- Company car or car allowance
- Health benefits, including Medical, Dental, and Vision
- 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