Study Start Up Manager

4 giorni fa

Milano, Italia AstraZeneca A tempo pieno

**Study Start-up Manager**

At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

The **Study Start-Up Manager (SSU Manager)** is responsible at country level for managing and conducting start-up activities within Site Management and Monitoring unit related to AZ sponsored clinical trials in compliance with the AZ procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations.

The **SSU Manager** will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.

The **SSU manager** works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.

If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.

**MAIN DUTIES AND RESPONSIBILITIES**
- Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality
- Actively participates in Local Study Team (LST) meetings
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
- Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
- Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Support Site Management & Monitoring in different initiatives (local, regional or global) as agreed with the SMM Line Management

**ESSENTIAL REQUIREMENTS**
- Scientific Degree or equivalent degree
- Experience (2 years) as Start-up specialist in a pharma company or CRO
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP and relevant local regulations
- Basic understanding of the drug development process
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management
- Excellent attention to details
- Good written and verbal communication skills
- Good collaboration and interpersonal skills
- Good negotiation and problem solving skills
- Good ability to learn and to adapt to work with IT systems
- Fluent in English and Italian

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