Late Development Clinical Operations Opportunities
4.
0 Gaithersburg, MD Gaithersburg, MD Full-time Full-time At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.
We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Our Oncology Research and Development Team Oncology is driven by speed.
Here you will be backed by leadership and empowered at every level to prioritize and make bold moves.
Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs.
Join a dedicated Oncology team that's growing fast and building a strong track record of success.
We make bold moves at the cutting-edge.
Transforming molecules to change the practice of medicine.
Some of the responsibilities you might have:
Responsible for leading a cross-functional study team to enable successful delivery of clinical studies from the onset of study specifications through to study archiving Mentor and empower a cross-functional team to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality in line with ICH/GCP and AZ relevant SOPs Be the key point of contact to the CRO project manager to ensure delivery to time, quality and cost; ensuring AZ oversight of the CRO is defined and performed across relevant AZ functions for outsourced studies Develop and maintain up to date study plans (e.
g.
global study management plan, monitoring plan, etc.
) ensure study level performance against agreed upon plans, lead proactive risk and contingency planning and raise issues as appropriate Provide input and hold accountability for the development of crucial study level documents (i.
e.
Clinical study Protocol) Select and lead vendors, handling their performance to ensure high quality, timely delivered services Ensure appropriate training is provided to the local teams, investigators and site staff as well as vendor teams as needed; taking an active role in the Investigators/Monitoring Meetings Set initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to leadership Ensure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelines Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection May be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and to inspire change for new ways to work You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures Why AstraZeneca? This is the place to make a meaningful impact - on patients' lives and your personal growth.
It's both rewarding and inspiring, and it's what keeps us motivated every day.
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 9 years Learn about our culture Learn more about working with us in Canada View our YouTube channel Are you interested in working at AZ, apply today! AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve.
In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca.
As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca's determination that the requested accommodation can be provided without undue hardship.
You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
AstraZeneca is committed to accommodating persons with disabilities.
Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing email protected .
.
Estimated Salary: $20 to $28 per hour based on qualifications.
0 Gaithersburg, MD Gaithersburg, MD Full-time Full-time At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.
We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Our Oncology Research and Development Team Oncology is driven by speed.
Here you will be backed by leadership and empowered at every level to prioritize and make bold moves.
Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs.
Join a dedicated Oncology team that's growing fast and building a strong track record of success.
We make bold moves at the cutting-edge.
Transforming molecules to change the practice of medicine.
Some of the responsibilities you might have:
Responsible for leading a cross-functional study team to enable successful delivery of clinical studies from the onset of study specifications through to study archiving Mentor and empower a cross-functional team to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality in line with ICH/GCP and AZ relevant SOPs Be the key point of contact to the CRO project manager to ensure delivery to time, quality and cost; ensuring AZ oversight of the CRO is defined and performed across relevant AZ functions for outsourced studies Develop and maintain up to date study plans (e.
g.
global study management plan, monitoring plan, etc.
) ensure study level performance against agreed upon plans, lead proactive risk and contingency planning and raise issues as appropriate Provide input and hold accountability for the development of crucial study level documents (i.
e.
Clinical study Protocol) Select and lead vendors, handling their performance to ensure high quality, timely delivered services Ensure appropriate training is provided to the local teams, investigators and site staff as well as vendor teams as needed; taking an active role in the Investigators/Monitoring Meetings Set initial operational study budget with the Clinical Program Team (CPT), and are responsible for study budget throughout the study, providing budget progress reports to leadership Ensure studies are inspection-ready at all times, according to ICH-GCP, AZ SOP and relevant policies/guidelines Responsible for the completeness of the Trial Master File; being the primary Study Management point-of-contact in the event of an audit or inspection May be assigned responsibility for leadership or participation in non-drug project work including applying process improvements methods and to inspire change for new ways to work You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures Why AstraZeneca? This is the place to make a meaningful impact - on patients' lives and your personal growth.
It's both rewarding and inspiring, and it's what keeps us motivated every day.
Great People want to Work with us! Find out why:
GTAA Top Employer Award for 9 years Learn about our culture Learn more about working with us in Canada View our YouTube channel Are you interested in working at AZ, apply today! AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve.
In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca.
As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca's determination that the requested accommodation can be provided without undue hardship.
You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
AstraZeneca is committed to accommodating persons with disabilities.
Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing email protected .
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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