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Project Specialist General Medicine Spain or UK

Employer
Syneos Health
Location
Spain or UK
Salary
Competitive
Start date
25 Feb 2021
Closing date
8 Mar 2021

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Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Here at Syneos Health we are currently recruiting for a Project Specialist to be based in our Spanish or UK office.

 

 

The role of the Project Specialist sits at the heart of the Clinical Trial Project Team. You will be a key point of contact for Project Leadership, Clinical Research Associates and site staff, performing various activities on assigned sudies in accordance with customer’s expectations and company SOPs.

 

This is a role in which strong communication and organisational skills are key to success, alongside the ability to work independently and organise and prioritise workload in order to meet deadlines in a dynamic environment.

 

A brief summary of duties the role will involve:

  • Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), patient enrolment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
  • Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
  • Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.
  • Provide administrative support to Project Leads and functional leads.
  • Ensure all study documents are archived based on the appropriate guidelines and policy.
  • Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

 

Minimal travel may be required (up to 25%).

 

Equal Opportunities Plan. Its objective is to achieve the principle of equality of opportunity in Syneos Health’s employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.

 

To succeed in the role, successful candidates should have the following skills/experience:

  • Prior experience in a similar role in the industry.
  • Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
  • Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
  • Strong organizational skills.
  • High proficiency with full MS Office Applications.
  • Ability to manage time and work independently to organize and prioritize work and meet deadlines 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. 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. 

 

Disclaimer: 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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