Project Specialist - Real World & Late Phase BU - UK
- Experience Level
- Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Project Specialist or Senior Project Specialist (dependent on experience) for our Real World & Late Phase Business Unit.
The role of the Project Specialist sits at the heart of the Clinical Trial Project Team. They are the right hand person to the Project Manager, providing support in ensuring the services and expectations of a Study are carried out in accordance with the contract and the customer’s expectations. The Project Specialist is a key point of contact for Project Leadership, Clinical Research Associates and site staff, providing administrative support using trackers, preparing documentation and updating meeting minutes and actions throughout the study life cycle.
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.
To succeed in the role, successful candidates should have the following skills/experience:
- Minimum of 12 months experience in a similar role in the industry.
- Degree educated of equivalent combination of education and relevant experience.
- High proficiency in full MS Office Suite and Outlook.
- 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
- High level of competence in English language.
- 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. Learn more about how we are shortening the distance from lab to life® at syneoshealth.com.
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. #LI-SP1