Associate Director Study Quality Jobs (NOW HIRING)

Strategic Team Supervision and Development

• Provide leadership, supervision, and mentorship to Feasibility Managers and Vendor Acquisition Managers, fostering a collaborative, high-performing team environment.
• Promote professional development within the team, including training, coaching, and performance feedback.
• Establish and maintain strong, collaborative relationships with internal cross-functional teams and external vendors to ensure alignment, high performance, and seamless study execution.
• Contribute to continuous departmental  improvement initiatives, including the development and optimization of tools, databases, processes, and best-practice SOPs to enhance operational efficiency and effectiveness

Clinical Trial Feasibility and Vendor Acquisition and Management Strategy 

• Analyze and synthesize data from trial sponsors, CROs, and internal cross-functional teams to comprehensively understand study objectives, protocol requirements, and operational needs.
• Conduct comprehensive feasibility assessments of study protocols leveraging internal databases, trackers, and dashboards to assess feasibility across the Care Access Site Network, identify appropriate vendor scope, and ensure alignment of feasibility and vendor capabilities with study needs for optimal execution.
• Translate feasibility findings into actionable recommendations that guide strategic planning, vendor selection, and resource allocation to support efficient and effective study execution.
• Responsible for managing key vendor performance activities and contributing to the delivery of vendor performance management across development operations.
• Contribute to the maintenance and application of vendor performance management frameworks, including performance metrics, issue management practices, escalation pathways, and performance improvement approaches.
• Prepare and deliver performance analytics and reporting for vendors, translating performance data into actionable insights to support governance discussions and continuous improvement activities.
• Provide clear, decision-ready insights and recommendations to internal stakeholders and vendor partners based on analysis of performance data, issue trends, and operational inputs
• Proactively identify, escalate, and resolve feasibility- and vendor-related challenges that could impact clinical operations, timelines, or study deliverables.

Cross-Functional Collaboration and Strategic Input

• Partner with Business Development, SSU, Finance, Operations, Legal,  and other stakeholders to align feasibility, vendor, and operational strategies with broader organizational objectives.
• Serve as a subject matter expert on feasibility and vendor considerations, providing insights and recommendations to support strategic decision-making.

Other Responsibilities

• Other duties as assigned based on evolving needs. 

• Strong understanding of clinical protocols, general clinical research processes, start-up workflows, and Good Clinical Practice.
• Prior clinical research experience with the ability to discuss protocol clinical aspects with vendors and internal stakeholders.
• Excellent interpersonal, written, and verbal communication skills; ability to build relationships across dispersed teams.
• High level of professionalism, confidentiality, and sound judgment; able to make evidence-based decisions.
• Experience working with site networks, sponsors, and CROs; direct site-based experience strongly valued.
• Proven leadership, judgment, and decision-making skills in a fast-paced, matrixed environment.
• Ability to manage multiple priorities, competing deadlines, and cross-functional initiatives effectively.
• Demonstrated ability to negotiate and 'sell' Care Access's value to vendors, sponsors, and investigators.
• Strong project and process management skills with a proactive, solution-oriented mindset.
• Analytical mindset with strong attention to detail, problem-solving skills, and ability to anticipate risks.
• Proficiency with Google Suite, Microsoft Office Suite, and data tracking for KPIs and vendor performance.
• Experience in creating and implementing new processes based on organizational needs.

• Minimum Education:
  • Bachelor's degree in life sciences, healthcare, nursing, or related field (advanced degree preferred).
• Minimum Experience:
  • At least 10 years of experience in clinical operations, feasibility, vendor management, or clinical trial start-up.
  • Proven vendor-facing experience within clinical trials, with the ability to engage investigators, site teams, sponsors, and CROs.
  • Familiarity with feasibility process, contracting workflows, and site activation processes.
  • Experience in Clinical Project Management is strongly preferred.
  • Proficiency with feasibility, CTMS, clinical portals, and project tracking tools.