Manager Study Support

AstraZeneca
Full time
Healthcare
United States
Hiring from: Anywhere

Manager Study Support



  • US


To lead, develop and provide direction to US Site Management and Monitoring local personnel to enable the delivery of local drug studies and non-drug projects by providing expertise (project, TA scientific, technical, and operational knowledge). To 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. To 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. The role holder will also be responsible for embedding consistent ways of working across SM&M and building the site management and monitoring capabilities.


Accountabilities



  • 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 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 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 processes 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 with ethics, policies, and standard procedures




Education:



  • 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

  • Line management experience

  • An understanding of the therapeutic areas related to AstraZeneca’s products

  • Comprehensive knowledge of clinical and pharmaceutical drug development process


Desirable



  • 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 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 more efficient and effective methods/processes of delivering quality clinical trials with a 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


Leadership Capabilities



  • Passion for customers

  • Thinks strategically

  • Acts decisively

  • Drives performance

  • Works collaboratively

  • Develops people & organization


AstraZeneca Values



  • We follow the science

  • We put patients first

  • We play to win

  • We do the right thing

  • We are entrepreneurial


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