Mgr, SSU & Regulatory

Description

Manager, Site Start-Up & Regulatory

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

• Conducts people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
• Provides guidance on administrative policies and procedures, technical problems, priorities, and methods.
• 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.
• Supports management with site start-up or maintenance 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 management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams.
• Interacts with the executive management and Legal Department and assists with the accurate creation and implementation of site contracts, site start-up, maintenance and regulatory management workflows. Identifies and reports on areas of process and risk.
• Implements 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 and reports based on input from functional teams. Provides input and requirements for long-range IT plans. Implements Company and customer-required project management systems and processes.
• Leads 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. 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
  
  

Qualifications

What we’re looking for

• Bachelor’s Degree.
• Experience in a clinical research organization and related contract management or site start-up experience.
• Background in development/management of information systems and process engineering preferred.
• 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.
• Demonstrate line management abilities.
• 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.
  
  

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

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.