Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us! We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day. Are you looking to make an impact? Then this could be the job for you!
Leading the Oncology US Site Management and Monitoring Study Start-Up team to execute the delivery of site startup activities for oncology studies.
Developing and deploying cross functional teamwork and coordination of the Study Start-Up Managers team resources to ensure optimal resource utilization and driving a best in class activation delivery focused on quality, efficiency and expediency.
Embedding consistent ways of working across the Study Start-Up group and building group capabilities.
Leadership of the SSU manager group, building the team spirit, developing team style and behavior
Assign skilled SSU managers to studies and sites
Provide oversight to SSU managers to ensure quality and timely site start-up activities in accordance with study timelines and clinical performance targets; start-up activities includes coordination and administration of clinical studies from start-up through site activation
Develop and implement efficiency measures in the activation process
Conduct routine review of activation output to identify challenges and best practices
Create a cross functional environment of best practice sharing and implement process change when applicable
Define SSU strategy and provide direction to SSU manager on study commitments
Ensure collaboration across US ONC SMM stakeholders including LSAD, contract managers, feasibility lead, site engagement lead and clinical research associate
Provide regular information and report to manager and US ONC SMM leadership team on study start up status and risk mitigation
Works with Directors within US SM&M to support capacity management, achieve accurate resource forecasting, analysis, and solution building to efficiently and flexibly resource the study SSU team
Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building, and issue resolution to facilitate achievement of objectives on time and to appropriate quality.
Ensure that the workload of the team(s) or direct reports are adequate
Development and performance management of the team(s) or direct reports
Ensure that everyone on the team or direct reports have development and training plans, according to IDP process
Ensure that the individual performance planning and review process is completed for all direct reports
Prepare salary and bonus proposals of all team members or direct reports based on their performance in close collaboration with responsible Director SMM and HR partner.
Ensure all systems are continuously updated and filing of SSU documents
Oversight of support systems and personnel (vendors) managing processes
Contribute to the quality improvement of the study processes and other procedures.
Plan and organize coaching of the team members and all direct reports
Act as first-line support for GCP and AZ processes
Promote and encourage innovation and creativity by bringing suggestions/good examples to SM&M leadership
Provide skills development and create opportunities for staff within the projects, drug, and non-drug projects.
Lead and support change by encouraging diversity of solutions that are value demonstrated
Promote and encourage communication within and across SM&M.
Role model and embed performance-driven culture.
Recruit and retain Site Management and Monitoring personnel.
Ensure compliance with ethics, policies, and standard procedures
Bachelor's degree required, preferably in medical or biological science, or related subject or equivalent qualifications or experience.
Five or more years of experience in the pharmaceutical industry working with the delivery of clinical studies
Extensive knowledge of clinical trial operational study activation processes
Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills
Good problem solving and conflict resolution skills
Manages change with a positive approach to the challenges of change for the self, team, and the business.
Sees change as an opportunity to improve performance and add value to the business
Ability to look for and champion effective methods/processes of delivering quality clinical trials with a reduced budget and in less time
Line management experience
Ability to work in an environment of remote collaborators.
Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team, and organizational objectives
Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global and regional
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
AstraZeneca 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 industry-leading 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 non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.