Senior Manager, Clinical Conduct

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the planning, implementation, and integrated governance of designated Future of Medicine initiatives across Clinical Conduct, Quality, Technology, and Operations.

• Convert clinical, operational, quality, and program requirements into scalable workflows, business and functional specifications, acceptance and readiness criteria, controls, Standard Operating Procedures (SOPs), training, and operational guidance.

• Collaborate with technical teams regarding feasibility, dependencies, testing, and execution.

• Spearhead readiness, change management, role-specific training, stakeholder engagement, launch execution, and post-launch reinforcement.

• Create decision-ready updates and recommendations for leadership; align stakeholders across matrices, facilitate decision-making, drive action closure, and ensure transparency regarding performance, trade-offs, risks, dependencies, and subsequent steps.

• Establish and monitor metrics for delivery, readiness, adoption, workflow quality, compliance, and the experience of participants and staff.

• Leverage qualitative and quantitative outcomes, root cause analysis, and pertinent external developments to prioritize and promote ongoing improvements.

• Collaborate with Clinical and Quality leaders to convert healthcare quality, regulatory, accreditation, Good Clinical Practice (GCP), and patient safety requirements into workflows, controls, training, and readiness criteria.

• Stay updated on scientific, methodological, regulatory, and operational advancements and translate relevant changes into program processes, requirements, training, or guidance.

• Provide mentorship, establish clear work expectations, and drive accountability through matrixed program leadership without formal personnel management responsibilities.

⛳️ Requirements

• Bachelor's degree in a healthcare-related field or an equivalent combination of education and relevant experience.

• A minimum of 7 years of progressively responsible experience in clinical research, clinical operations, healthcare quality, clinical technology, program management, or similar regulated healthcare operations.

• Proven experience leading complex, cross-functional programs in regulated healthcare or clinical operations from strategy to implementation and sustained adoption.

• Experience in designing scalable processes and producing high-quality SOPs, process flows, training materials, job aids, and guidance documentation.

• Ability to translate business, clinical, and operational needs into functional specifications, workflow outlines, acceptance criteria, and implementation strategies in collaboration with technical teams.

• Demonstrated capacity to influence senior stakeholders, align matrixed teams, facilitate decision-making, and convert strategy into actionable work.

• Sound judgment in ambiguous, high-pressure situations, including appropriate risk assessment and resource escalation.

• Experience in coaching cross-functional team members, establishing clear expectations, and fostering accountability through shared or matrixed leadership.

• Strong analytical and problem-solving abilities, including root cause analysis and the application of qualitative and quantitative data.

• Familiarity with GCP and regulated clinical research or healthcare environments is preferred.

• Experience leading the adoption of technology-enabled workflows and utilizing work management platforms like ClickUp or similar tools is preferred.

• Direct experience supporting clinical research operations or clinical trial delivery is preferred.

• Must be able to perform all work in a remote office setting.

• Care Access is currently unable to sponsor work visas.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays.

• 100% Employer-paid medical, dental, and vision insurance plan options.

• Health Savings Account and Flexible Spending Accounts.

• Bi-weekly employer contributions to HSA.

• Company-paid Short-Term Disability and Long-Term Disability.

• 401(k) Retirement Plan with Company Match.