Associate Director, Clinical Trial Management - Full-Service
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
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 leadership, direction and management to Clinical Trial Managers (CTMs/Sr CTMs). Oversees the quality related to monitoring and site management activities to ensure clinical deliverables are met. Acts as primary point of contact for monitoring strategy and alignment both internally and externally for assigned studies. May liaise with other departments or business units to optimize resources as well as to harmonize central monitoring and clinical operations practices, processes and tools. Contributes to operational initiatives and continuous improvement. Uses, metrics, dashboards and reports to analyze compliance and quality of services to ensure clinical operations/central monitoring delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures. Participates in the financial review of project status and drives project financial performance, particularly as related to clinical operations/central monitoring services.
Core 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 current knowledge of industry trends and “current-thinking”.
•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).
•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 operational oversight and guidance to support prioritization of activities, reviews and monitors the work…