12 oct
|
3212 Syneos Health Clinical Spain, S.L.U.
|
España
12 oct
3212 Syneos Health Clinical Spain, S.L.U.
España
Site Activation Manager/Clinical Operations Manager_ Madrid/Spain.FSP Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.supportive and engaged line management; technical and therapeutic area training; Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job ResponsibilitiesThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.Ownership of country and site budgets.Development,
negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments.
Payment reconciliation at study close-out.Executes and oversees clinical trial country submissions and approvals for assigned protocols.Develops local language materials including local language Informed Consents and translations.Responsible for quality and compliance in assigned protocols in country.Contributes to the development of local SOPs.Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.Provides support and oversight to local vendors as applicable.Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, a
📌 Site Activation Manager/Clinical Operations Manager_ Madrid/Spain. Fsp (España)
🏢 3212 Syneos Health Clinical Spain, S.L.U.
📍 España