Senior Study Start Up & Regulatory Specialist - 6 month contract
Senior SSU & Regulatory Specialist
Office-based in Farnborough or UK Home-based
6 month contract
Here at Syneos Health we are currently recruiting for a Senior SSU & Regulatory Specialist to sit within our country SSU department.
You will perform assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise, with minimal oversight from the SSU Country Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. Accountable local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction of the Project Lead (PL) or SSUL as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PL/SSUL at the project level and line manager for deliverables. May act as the Country Start-Up Advisor (CSA) or as a line manager / mentor for less experienced staff. At a project level, may act as SSUL for local or regional studies.
The ideal candidate will need the following experience / skills to be considered:
- Bachelor’s Degree
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good understanding clinical protocols and associated study specifications
- Excellent understanding of clinical trial start-up processes
- Project management experience in a fast-paced environment
- Good vendor management skills
- Strong organizational skills with proven ability to handle multiple projects
- Excellent communication, presentation and interpersonal skills
- Quality-driven in all managed activities
- Strong negotiating skills
- Strong problem-solving skills
- Ability to mentor, lead and motivate more junior staff
- Demonstrate an ability to provide quality feedback and guidance to peers
- Contribute to a training and Quality assurance plan within SSU and update SOPs/WI
We have a comprehensive benefits package and offer highly competitive remuneration.
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 https://www.syneoshealth.com/
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