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