Senior Manager, Clinical Conduct

Summary

Join Care Access as a Senior Manager of Clinical Conduct and lead the development and implementation of operational processes and clinical quality within the Pre-screening program. You will spearhead initiatives, coordinate cross-functional work streams, and ensure compliance with regulations. Responsibilities include operational planning, project timeline tracking, staff training, and stakeholder collaboration. The role requires a Bachelor’s degree in a healthcare-related field, 5+ years of clinical research experience, and excellent knowledge of GCP guidelines. This remote position offers less than 15% travel and includes benefits such as PTO, comprehensive insurance, an HSA plan, disability and life insurance, a 401k plan, and a culture of growth and equality. The ideal candidate will possess strong technical and analytical skills, experience in stakeholder management, and proficiency with various software programs.

Requirements

• Willingness to work collaboratively and incorporate diverse perspectives into decision-making
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
• Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and project teams to turn vision into reality
• Deep knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle
• Prior managerial experience
• Strong technical/analytical skills to identify and solve problems independently
• Function well under pressure in a changing environment
• Work with virtual/agile teams in different locations, aligning and adapting to different work, culture, and communication styles
• Ensure smooth cross-functional liaisons with critical functions for project success
• Proficiency working with Microsoft Office Program Suite including Word, PowerPoint, Excel in addition to Microsoft SharePoint and Microsoft Teams
• Experience training staff on new technologies in a way that helps to promote adherence and compliance throughout the project
• Proficiency with project management tools such as Monday.com
• Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and project teams to turn vision into reality
• Bachelor’s degree in a healthcare-related field
• 5+ years of experience in clinical research
• Excellent knowledge of GCP guidelines

Responsibilities

• Lead development and implementation of pre-screening program initiatives including adherence to regulations for practicing medicine, collecting patient data, and referring to clinical trials
• Lead operational planning of the Care Access pre-screening program by coordinating cross-functional work streams across clinical operations, technology, and leadership teams
• Assist in tracking project timelines, preparing materials for internal and external meetings, and ensuring resolution of action items
• Lead maximizing the program delivery process efficiency through design, development and implementation of training, documentation, SOPs, and internally facing guides
• Ensure critical capabilities and competencies essential for patient safety and operational success by supporting training of staff on new program details and technology features and answering questions
• Ensure compliance with regulatory and accreditation requirements related to training and development
• Collaborate with stakeholders and leadership across the enterprise, including clinical, IT, operations, to identify training needs and create a comprehensive learning strategy for the team
• Ensure aligned deliverables are in place, and project plans are adhered to with respect to quality, and in line with organizational priorities
• Maintain awareness of new scientific and methodological developments within therapeutic area

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision Insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life Insurance
• Culture of growth and equality
• 401k retirement plan