Local Study Leader

Do you want to transform the practice of medicine to impact patients’ lives? Do you want to be trusted and empowered to innovate?

At AstraZeneca we lead with the science first and foremost. As a patient centric global pharmaceutical company, we know that strong science leads to clinical innovation and the right medicine for the right patient. Importantly, we are keen to meet people who are passionate about the science and what to make an impact on people’s lives. Here you will have the opportunity to get to make your mark as you do something rewarding for patients, healthcare and our wider society. Jump in and be a part of it.

SITE DESCRIPTION

Welcome to Athens, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self.

BUSINESS AREA

In the Biopharmaceuticals Business Unit we thrive in our diverse and vibrant environment. Part of a global research-led enterprise, there’s always novel science to bring to market. It brings out the best in us – provided with all the support and tools needed and the agility to move fast. Unleash your ambition and your true self. Part of our inclusive environment where there’s opportunity for global mobility, continuous learning and building best practices.

We have an opportunity for a Local Study Leader.

The Local Study Leader is responsible of leading Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the  Local Study Leader (LSL) may perform site monitoring as needed to support the flexible capacity model. The LSL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

What you will do

• Lead and optimise the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
• Ensures timely preparation of local Master CSA
• Sets up and maintains the study in CTMS at study country level
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans
• Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters
• Reports study progress/update to the Global Study Associate Director/ Global Study Team
• Contributes to patient recruitment strategy including regular communication with participating Investigators
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level
• Ensures accurate payments
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”

Essential for the role

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
• Minimum 2 years of experience in Clinical Development Operations (Study Manager)
• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
• Project management skills
• Team building
• Ability to prioritize and handle multiple tasks
• Attention to details
• Ability to learn and to adapt to work with IT systems
• Fluent in Greek and English

Desirable for the role

• Medical knowledge and ability to learn relevant AZ Therapeutic Areas
• Analytical skills
• Financial management skills

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.