Syneos Health

SSU Project Delivery Manager/Senior SSU Project Delivery Manager

Location
Home Based anywhere in Europe
Salary
Negotiable
Posted
05 Aug 2019
Closes
19 Aug 2019
Ref
LA-19004533
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

19004533

SSU Project Delivery Manager/Senior SSU Project Delivery Manager
Home based anywhere in Europe

At Syneos Health we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.

As a Study Start Up Project Delivery Manager you will work on a global level, traversing all therapeutic areas and phases, providing your expertise at this vital period of time in the study. Strong expertise at this critical time has resulted in our average study start up time being four weeks faster than industry standard.

 

A brief summary of duties you will be involved in:

  • Acting as a key point of contact with the sponsor and internal team regarding all regulatory activities for the assigned study
     
  • Overseeing all associates assigned to work on the regulatory, ethics and essential document portion of the study
     
  • Assuming responsibility on deliverables at the project level
     
  • The planning, coordination and oversight of all processes involved in gaining approvals required in each country for a clinical trial to commence. This will include competent authority approvals, ethics committee approvals, import license approvals, radiation approval, tissue/biological sample export and any other local approvals required in a given country.
     
  • Dealing with multiple countries and studies at any given time.

 

To succeed in this role you will need the following skills/experience:

  • Degree educated or equivalent in a science or healthcare field 
     
  • Minimum 5 years CRO industry experience and/or a minimum 4 years’ experience working in a SSU or clinical trial environment
  • Experience with leading/co-leading multiple studies from award and into maintenance; at least 2 of those studies must have included more than 10 countries across multiple regions
  • Excellent understanding and experience in regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in multiple European, APAC and Americas countries     

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. Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Learn more about how we are shortening the distance from lab to life® at syneoshealth.com.

     

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.

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