Oncology Study Start-Up Associate Director

[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 coordinatination 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.
• Embeding consistent ways of working across the Study Start-Up group and building group capabilities.

[Typical Accountabilities]

• 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 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 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.

[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 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.
• 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.

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