Group Director Study Operations Oncology RD
Group Director Study Operations Oncology RD
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Job Description
At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledgesharing 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 facetoface in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind providing space where teams can come together to strategize brainstorm and connect on key projects.
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 were taking ambitious action to tackle some of the biggest challenges of our time from climate change to access to healthcare and disease prevention.
The Group Director Study Operations is accountable for the management and development of a team of clinical operations specialists supporting the delivery of clinical studies and will lead or participate in functional activities supporting day to day business as well as change and improvement projects.
The Group Director Study Operations may also take on the responsibilities of the Director Study Leader for delivering development programs or leading multiple studies / single complex studies. The exact accountabilities will differ and so a high degree of flexibility and autonomy is required.
Key Responsibilities:
Management development and career progression of clinical operations specialists
Recruitment and retention of staff
Ensure direct reports are appropriately trained and developed to align with company and regulatory standards
Conduct ongoing performance management and complete the required steps of the performance management cycle Resource management and efficient deployment of staff to clinical studies/programs
Oversight of quality and compliance of the group to ensure inspection readiness
Driving efficiencies and innovation across the operational skill group
Work closely with the Leadership Team to drive strategy and business performance
Development and maintenance of processes owned by the group
Driving productivity improvements and innovation within the group
Lead/participate/represent Study Operations in strategic work streams
In addition to the full line management accountabilities the Group Director Study Operations may undertake responsibilities of the Director Study Leader Early Oncology Clinical:
Provides expert clinical operational input into project or study level documents for example clinical development plan clinical study protocol clinical study report and may lead the delivery of study documents
With oversight from the Senior Director may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
Leads the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget time project standards quality and scientific standards
Accountable for overall study or program deliverables maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
Ensure sponsor oversight throughout the life of the study
Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality budget and raise issues to collaborators as appropriate
Responsible for planning and leading customer concern resolution
Provide input to forecasting and management of study/program delivery costs resource and timelines
Accountable for the quality of study/program planning information into relevant planning systems
Date: September 2021
AstraZeneca Job Profile
Mentors and supports development of individuals within the organisation
Contributes to operational interactions with external entities including regulatory agencies preferred partners/suppliers and external collaborators
Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
Responsible for study or program level reporting of progress risks and issues
Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
Provision to procurement clear specifications for study or program specific outsourcing
Review and operational approval of study or program specific contracts or work orders
Essential Education Skills & Experience:
University degree in related discipline preferably in medical or biological science or discipline associated with Clinical Research
Significant experience in operational support and delivery in early clinical development
Experience of working with and delivering through strategic partners and 3rd party vendors
Excellent knowledge of ICHGCP principles
Team orientated
Ability to lead coordinate and prioritise multiple tasks and deliverables
Proactive approach
High degree of flexibility
Demonstrated verbal and written communication skills
Good negotiation and collaboration skills
Demonstrated interpersonal and problemsolving skills
Ability to manage change and actively seek and champion more efficient and effective ways of working
Some travel may be required
Desired Education Skills & Experience:
Higher degree e.g. PhD MSc MPhil
Program management qualification (e.g. MBA PRINCE2 PMP)
Experience in variety of academic/CRO/Sponsor organisations and countries
Line management experience
Great People want to Work with us! Find out why:
Are you interested in working at AZ apply today!
AstraZenecais 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.
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Date Posted
10Mar2025Closing Date
23Mar2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Director
Employment Type
Full-Time
