Associate Director, Clinical Trial Management - Full-Service

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 performed, metrics compliance, and development of contingency plans, among others.

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.

Participates in 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 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 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.

Participates in marketing activities, client presentations and proposal development.

Line Management responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counseling of staff.

Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.

Liaises with resourcing management on active awarded and proposal project assignments.

Reviews workload, utilization, productivity, and quality for staff in reporting chain.

Manages the resource availability for the assigned staff, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions.

Support the assessment of overall staff growth and actively participate in the selection and hiring process.

Proactively works to ensure staff retention and turnover rates remain within expected levels.

Ensures all staff follows required training and completes the required documentation.

Provides regular compliance updates to management accordingly.

Participates in audits of clinical trial management delivery and prepares others for participation in audits

Additional Qualifications

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