Global SSU & Regulatory Maintenance Specialist
Global Site Start Up & Regulatory Maintenance Specialist II
Office-based in Farnborough or Edinburgh
Home based is a possibility
Here at Syneos Health we are currently recruiting for a Global SSU & Regs Maintenance Specialist II. Performs assigned activities within the SSU Central Service Life Cycle Maintenance Team that support SSU activities as needed, for studies which have completed site activation, in all phases of clinical trials related to investigational drugs, biologicals and medical devices as required.
- Assumes accountability on SSU deliverables including, but not limited to:
Life cycle maintenance amendment activities; Communication and coordination with country start- up specialists for all RA, IEC/IRB submission deliverables; Overall SSU timelines for life cycle maintenance amendment activities; Communication and coordination with Site Contract Negotiator(s) for amendments to contracts and/or budget independent to the submission deliverables.
- Collaborates with all major functional area leads.
- Ensures all project deliverables meet the internal customers’ and client expectations.
- Maintains plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables.
- Reviews the project budget for out of scope activities for life cycle maintenance activities in collaboration with Project Lead (PL) to ensure project profitability.
- Uses corporate tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks. If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work.
- Prepares the core submission documents and core clinical trial application dossier and obtains agreement from the Sponsor on package contents in line with the Regulatory Impact Assessment.
- Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams.
- Accountable for the timely follow-up for Ethics Committee/Regulatory Authority enquiries or objections in collaboration with the country start up- specialists.
- Oversees the timely provision for filing of submission documents to the study’s Trial Master File in collaboration with the country start-up specialist.
- Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.
The ideal candidate will need the following experience / skills to be considered:
- Bachelor’s Degree.
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to understand clinical protocols and associated study specifications.
- Detailed understanding of clinical trial start-up processes.
- Ability to manage external vendors to contract effectively.
- Strong organizational skills with ability to handle multiple tasks effectively.
- Strong written and verbal communication and interpersonal skills.
- Ability to manage multiple project budgets with increased complexity and value.
- Quality-driven in all managed activities.
- Good negotiating skills.
- Good problem-solving skills.
- Demonstrated ability to work independently as well as part of a team.
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.
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