At AstraZeneca, we win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do!

As the Manager of Study Support, you will lead, develop and provide direction to US Site Management and Monitoring (SM&M) local personnel to enable delivery of local drug studies and non-drug projects by providing expertise (project, TA scientific, technical and operational knowledge). You will work collaboratively across US SM&M to manage and coordinate SM&M resources within SM&M, thus ensuring optimal resource utilization and consistency of the site management and monitoring capabilities.  

The Manager of Study Support will work in collaboration with the Associate Directors in SM&M regarding resourcing in support of delivery of local clinical studies from feasibility to CSR and study closed and archived. You will also be responsible for embedding consistent ways of working across SM&M and building the site management and monitoring capabilities.

Main Duties and Responsibilities

Provide appropriately skilled Site Management and Monitoring personnel to local study delivery teams to ensure delivery of clinical studies to time, budget and quality through an integrated skill set model in accordance with clinical performance targets

• Works with Associate Directors within US SM&M to support Capacity Management, achieve accurate resource forecasting, analysis and solution building to efficiently and flexibly resource local study teams
• Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality.
• Ensure that the workload of the team(s) or direct reports is 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 training plans/trainings are completed via SABA within required 30-day certification timelines.
• 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 Associates Director SMM and HR partner.
• Ensure all systems are continuously updated.
• Oversight of support systems and personnel (vendors) managing process of data input: (TMF, Impact, Angel, iBUY, ISF, ISL distribution, record management).
• 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.
  • Contribute to the business through drug/non-drug project or departmental activities.
  • 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 to ethics, policies and standard procedures

Essential Requirements

• Bachelor’s degree required, preferably in medical or biological science, or related subject
• Five or more years of experience in the pharmaceutical industry working with delivery of clinical studies
• Line management experience
• An understanding of the therapeutic areas related to AstraZeneca’s products
• Comprehensive knowledge of clinical and pharmaceutical drug development process

Desirable Requirements

• 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
• Manages change with a positive approach to the challenges of change for 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 more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
• Good problem solving and conflict resolution skills
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment

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 recognizing their potential. Join us on our journey of building a new kind of organization 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.

Come and join our journey - Apply today!

#ClinicalStudyManagement

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

03-Aug-2021

Closing Date

03-Oct-2021

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.