DescriptionExecutive Director, Clinical Trial ManagementCome discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.Why Syneos Health- #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves.- Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.- We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.Job Responsibilities- Provides expert monitoring strategy, oversight and guidance to support internal teams and sponsors. Includes defending the rationale for monitoring strategy, process and tools and maintaining expert-level current knowledge of industry trends and "current-thinking". May represent Syneos Health at industry events, through publications and other contributions to thought leadership in the industry.- Guides internal teams and sponsors through and documents the key decisions needed to implement a high quality, efficient risk-based monitoring (RBM) solution. This includes close interaction with project management, data management, quality assurance, biostatistics, medical monitoring and data operations technical support (DOTS).- Sets expectations for and oversees the identification of critical data and process, the assessment of risks to protocol execution and clinical delivery, risk and issue tracking and risk and issue mitigation strategies.- Where sponsors desire to incorporate new data sources, technologies or new/supplemental/substitute processes to support RBM, strategizes with internal team members and sponsors to agree on "hybrid" approach that is efficient and effective.- Works with internal team members and sponsors to ensure access to data needed to execute RBM according to the agreed plan.- Provides expert operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others. This expertise should extend from site activation through database lock.- Analyzes performance and quality metrics to assure BU achievement of quality and compliance expectations related to patient safety and data integrity as well as RBM success measures.- Functions as point of escalation for clinical, central monitoring, RBM and project risks and issues. Oversees progress of teams supporting clinical projects. Ensures individual and team tasks are completed according to requirements per Sponsor/Customer expectations and contract.- Leads work streams to support the development and implementation of new initiatives and strategic direction of the BU, cross-BU 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 country/region specific and government regulations and per Sponsor/Customer expectations and contract.- Develops and supports customer relationships, manage customer expectations and escalates more serious risks and issues as required.- Works closely within appropriate business unit/region to ensure staff performance on studies and corrects deficiencies as identified by staff, clients, and auditors.- Identifies needs and may make recommendations for process improvement and efficiencies. Seeks appropriate approval for initiating and leading workstreams to avoid duplication or competing budget/resources.- Participates in committees and work groups to support the development and implementation of new initiatives and strategic direction of the BU and cross-BU Clinical Operations.- Provides support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required.
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