Syneos Health

Manager, SSU & Regulatory (Serbia)

Serbia, SRB
14 Apr 2021
13 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
As a SSU & Regulatory Manager you will be managing work and teams within an area of site start-up, such as: site activation, regulatory/ethics submissions, site contracts, and/or life cycle maintenance activities.

Main responsibilities include:
  • Performing operational level planning, including efficient allocation of resources within the department.
  • Interacting with the executive management and Legal Department and assisting with the accurate creation and implementation of site contracts, site start-up, maintenance and regulatory management workflows.
  • Ensuring fulfillment of customer requirements and compliance with related regulations.
  • Providing guidance on administrative policies and procedures, technical problems, priorities, and methods.
  • Identifying and reporting on areas of process and risk. Developing strategy for process improvement.
  • Participating in business development presentations as a subject matter expert in Site Start-Up & Regulatory functions within the Company.
  • People management activities including: interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
The ideal candidate will need the following experience / skills to be considered:
  • Experience in a clinical research organization and related contract management or site start-up experience.
  • TMF background desired.
  • 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/coach team members to reach performance objectives.
  • Ability to recognize and take appropriate action when employee performance is not acceptable.

If you have the required experience for this position and are eligible to work in the required location then please apply by CV.

To find out more about our company and search and apply for other open jobs please visit our website

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.


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