Study Start-Up Managers EU CTR
Study Start-Up Managers EU CTR
Locations: Across Europe where we have an Site Management & Monitoring (SMM) presence
Competitive salary and benefits
Make a more meaningful impact to patients’ lives around the globe
Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
Join the team that follows the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs.
This role - internally known as a EU CTR Part 2 Coordinator (P2C) - is responsible for project management and coordination of the EU CTR Part 2 submissions together with global regulatory, global study team and local study teams from the participating countries in compliance with the EU CTR requirements, AZ procedures, documents, local and international guidelines and relevant regulations. The creation of this team is hugely exciting and these positions are pivotal to the success of the program. You will receive specific training during the onboarding process. These roles would suit candidates with Local Study Associate Director (Manager) level experience.
Management, coordination and collation of Part 2 packages
- Attend the global submission planning kick off meeting(s)
- Agree on timeline planning for submission with global and local teams.
- Ensure local teams are fully aware of submission timelines to allow robust SQV’s / site selection visits to occur with EU/EEA sites
- Ensure global documents are provided to local teams in time for Part 2 package preparation. Hold global team accountable for delivery.
- Collate Part 2 submission Table of Content (ToC) and corresponding part 2 documents completed by local study associate directors.
- Reach out to the countries to ensure ToC reflects the country submission documents and meets the EU CTR requirements
- Check completeness, not content, of Part 2 submission packages (downloaded documents) with ToC
- Hold EU/EEA local teams accountable to the delivery of the part 2 package to the agreed timelines
Provide support to local teams
- EU CTR specific questions
- Questions on document content
- Provide support and coordinate Part 2 RFI responses
- Ensure agreement between local teams and global teams on translations as required (CTIS fields, CSP synopsis, cover letter etc.)
Collation of Part 2 substantial modifications, non-substantial modifications and notifications
- Handling of Part 2 substantial and non-substantial modification requests and notifications from countries – coordinate submissions together with any Part 1 substantial modification
- Fully understand the EU CTR regulation, AZ regulatory and clinical trial start up process
- Understands AZ study operation model on global and local level
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification and experience
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP
- Basic understanding of drug development process
- Good collaboration and interpersonal skills
- Excellent verbal and written communication skills
- Excellent attention to details.
- Excellent understanding of Clinical Study Management and study start-up
- Good negotiation skills
- Good ability to learn and to adapt to work with IT systems.
- Integrity and high ethical standards
- Good analytical and problem-solving skills
- Basic change management skills
- Good intercultural awareness
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
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. Always committed to lifelong learning, growth and development.
So, what’s next?
This role is open from (Day, Month, Year). We will continuously review candidates on an ongoing basis, so there’s a chance this role will close shortly, should we fill all of the positions.
Where can I find out more?
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