Senior Manager, Clinical Conduct

🇺🇸 United States - Remote
🌐 All Others🟠 Manager

Job description

What We Do:

Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are:

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and have a long-term impact on generations.

Position Overview:

The Senior Manager of Clinical Conduct will lead the development and implementation of operational processes and clinical quality through cross-functional coordination and training and support of staff within the Care Access Pre-screening program.

What You’ll Be Working On (Duties include but not limited to):

  • 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

Physical and Travel Requirements:

  • This is a remote position with less than 15% travel requirements. Occasional planned travel may be required as part of the role

What You Bring (Knowledge, Skills, and Abilities):

  • 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

Certifications/Licenses, Education, and Experience:

  • Bachelor’s degree in a healthcare-related field
  • 5+ years of experience in clinical research
  • Excellent knowledge of GCP guidelines

Benefits (US Full-Time Employees Only):

  • 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

Diversity & Inclusion:

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the

physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

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