Senior Study Start Up & Regulatory Specialist
- Contract Type
Senior Study Start-Up & Regulatory Specialist/COM
Syneos Health has recently formed a new partnership with a leading pharmaceutical organization. Due to this new partnership, Syneos Health is seeking a Senior SSU & Regulatory Specialist to be fully outsourced and dedicated to this partnership. You will act as Clinical Operations Manager (COM) for the client and will be fully integrated in to a dynamic and friendly team.
You will be accountable for execution and oversight of local operational clinical trial activities in the UK & Ireland for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The COM takes ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Financial forecasting and maintenance of financial systems.
The COM is responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Interactions with IRB/IEC and Regulatory Authority for assigned protocols. Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
The ideal candidate will need the following experience / skills to be considered:
- Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent health Care related experience.
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submissions and approval processes, and understanding of how these impact study start-up.
- Able to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues.
- Problem solving is essential to this position
- Excellent communication skills
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/
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.