Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
THIS IS A REMOTE POSITION
Summary of the group
To lead 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 Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.
The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Must have experience in hematology or cell therapy
Main Duties & Responsibilities
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
* Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
* Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
* Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
* 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. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
* Ensures timely preparation of country financial Study Management Agreement 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 (including site budget) and amendments as needed.
* Ensures 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.
* Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
* Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
* 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.
* Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
* Proactively identifies risks and facilitates resolution of complex study problems and issues.
Education & Experience Requirements:
Minimum Requirements
Bachelor degree in related discipline, preferably in life science and
Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
* 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.
Must have experience in hematology or cell therapy
Required Skills
* Excellent project management skills.
* Excellent team building and interpersonal skills.
* Excellent organisational skills.
* Excellent verbal and written communication skills.
* Excellent ability to prioritize and handle multiple tasks.
Excellent knowledge of spoken and written English.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
15-Nov-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.