Work as Study Start Up & GCP Quality Responsible at Roche
At Roche they focus on developing medicines and diagnostics that will help patients live longer, better lives.
They strive to address unmet medical needs through excellence in science – from early detection and prevention of diseases to diagnosis, treatment and treatment monitoring.
Post : Study Start Up & GCP Quality Responsible
The Study Start-up Specialist is responsible for all Study Start Up (SSU) related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.
- You will execute all start-up activities prior to site activation on assigned studies, according to Roche standards and aligned with study/project requirements and timelines
- You will prepare country level Informed Consent Form (ICF) and obtain ethics committees and local regulatory authorities’ approval. You will also prepare ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country
- You will maintain and analyze study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
- You will partner with Clinical Study Managers (CSM5) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethics requirements, track and drive site activations and trial amendments submissions by regularly reviewing and monitoring status of submissions/activations
- You will support drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department as required and will also be responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate as required and ensure compliance with Fair Market Value (FMV) in the country
- You are a Graduate preferably in Medical/Science related field, have demonstrated knowledge and understanding of clinical trials and have experience of 3 -5 years in managing projects (previous line management experience is preferred)
- You have understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practices
- You have understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country
- You are someone who creates novel solutions with measurable value for existing and potential customers
Location: Maharashtra, Mumbai
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Development
Job ID: 3409047407
End Date: 3rd August, 2017
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