Oncology Study Start-Up Associate Director

hace 4 semanas

Barcelona, España Astrazeneca Gmbh A tiempo completo

[Responsible for] Leading the ONC US Site Management and Monitoring Study Start-Up team to execute the delivery of site start-up activities for oncology studies.Developing and deploying cross-functional collaboration 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.[Typical Accountabilities] Leadership of the SSU manager group, building 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 include 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 reports to manager and US ONC SMM leadership team on study start-up status and risk mitigation.Work 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 is adequate.Development and performance management of the team(s) or direct reports.Ensure that everyone on the team or direct reports has 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 for 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 a performance-driven culture.Recruit and retain Site Management and Monitoring personnel.Ensure compliance with ethics, policies, and standard procedures.[Essential] 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.Comprehensive 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 self, team, and 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.Leadership Capabilities.[Desirable] 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 context.
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