Associate Director, SSU & Regulatory (Line Manager)
- Experience Level
- Experienced (non-manager)
Assists in developing, implementing, and analyzing work within a specific or broad area of site start-up, such as site activation, regulatory/ethics submissions, site contracts, and/or post activation activities. Ensures fulfillment of customer requirements and compliance with related regulations. Analyzes processes and develops strategies to increase efficiency. Performs operational planning at the department or business unit level, including efficient allocation of resources within the department. Functional Profit/Loss (P/L) responsibility for assigned projects, programs, and/or a portfolio of work. Supports business development selling efforts and may directly represent the Company in functional service opportunities.
• Oversees people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
• Ability to mentor and coach managers and supports team managers on all administrative or departmental activities.
• Facilitates processes, resourcing, and communications within a department, across departments, or within the country assigned.
• Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues.
• Plans and negotiates resources with line management of functional areas.
• Serves as a departmental point of escalation for internal and external customers.
• May be responsible & accountable for the effective operations and SSU project deliverables across all regions, within the assigned programs/projects.
• Develops and maintains strategic relationships with customers. Collaborates with business leads for business development, alliance management, contracts and proposals development, project management, clinical management, operational personnel, and executive management to achieve project goals.
• Ensures that individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed.
• Supports management with site start-up and financial management tasks of projects, as well as strategy development for process improvement.
• Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis.
• Supports reporting of department and team metrics/cycle times and strategies to improve metrics/cycle times Guarantees SSU delivery of assigned projects and/or initiatives.
• Involved in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams.
• Interacts with internal or external Legal Departments and assists with the accurate creation and implementation of contract management workflows or with the contract management group. Identifies and reports on areas of process and contract risk.
• Oversees the implementation of customer-required and/or enterprise-wide project management systems and tools. Participates in the development, implementation, and maintenance of enterprise project management systems, acting as a systems manager; may supervise a systems administrator.
• Develops requirements for modifications to existing systems, metrics and reports based on input from functional teams. Provides input and requirements for long-range IT plans. Implements Company and/or customer-required project management systems and processes.
• Leads larger teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes. Develops and implements strategies and tools for tracking contract management team metrics/cycle times.
• Responsible for creating a predictable project experience for both employees and clients alike.
• Contributes to and may lead change initiatives across the SSU and Regulatory department.
• Develops and implements strategies and tools for tracking metrics/cycle times. Oversees all quality control efforts of individual departmental teams.
• Represents the Company at professional meetings or seminars.
• Establishes and maintains training materials for assigned area.
To succeed in this role you will need the following skills/experience:
• Bachelor’s Degree
• Experience in managing teams of clinical research employees
• Strong leadership skills; ability to teach/mentor team members
• Ability to coach employees to reach performance objectives
• Ability to recognize and take appropriate action when employee performance is not acceptable
• Extensive Clinical Trial experience
• Sales experience preferred.
• Strong knowledge of clinical research management processes.
• Understanding of the needs of countries and the ability to work across geographic regions.
• Strong CRO operational experience with a track record in project management working in an international or global capacity.
• Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
• Strong presentation, documentation, and interpersonal skills.
• Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.