Study Start-Up Managers EU CTRLocations: Across Europe where we have a Site Management Monitoring (SMM) presenceCompetitive salary and benefitsMake 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.Typical accountabilities:Management, coordination and collation of Part 2 packagesAttend the global submission planning kick off meeting(s)Agree on timeline planning for submission with global and local teamsEnsure local teams are fully aware of submission timelines to allow robust SQV's / site selection visits to occur with EU/EEA sitesEnsure global documents are provided to local teams in time for Part 2 package preparation.
Hold global team accountable for deliveryCollate Part 2 submission Table of Content (ToC) and corresponding part 2 documents completed by local study associate directorsReach out to the countries to ensure ToC reflects the country submission documents and meets the EU CTR requirementsCheck completeness, not content, of Part 2 submission packages (downloaded documents) with ToCHold EU/EEA local teams accountable to the delivery of the part 2 package to the agreed timelinesProvide support to local teams for EU CTR specific questions and document contentProvide support and coordinate Part 2 RFI responsesEnsure 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 notificationsHandling of Part 2 substantial and non-substantial modification requests and notifications from countries - coordinate submissions together with any Part 1 substantial modificationEssential criteria:Fully understand the EU CTR regulation, AZ regulatory and clinical trial start-up processUnderstands AZ study operation model on global and local levelBachelor degree in related discipline, preferably in life science, or equivalent qualification and experienceGood knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDPBasic understanding of drug development processGood collaboration and interpersonal skillsExcellent verbal and written communication skillsExcellent attention to detailsExcellent understanding of Clinical Study Management and study start-upGood negotiation skillsGood ability to learn and to adapt to work with IT systemsDesirable criteria:Integrity and high ethical standardsGood analytical and problem-solving skillsBasic change management skillsGood intercultural awarenessAbility to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less timeDemonstrates ability to prioritize and manage multiple tasks with conflicting deadlinesTeam oriented and flexible; ability to respond quickly to shifting demands and opportunitiesWhy AstraZeneca: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?Where can I find out more?
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