FreshRemote.Work

Director of Clinical Solutions Design ($150k - $175k per annum plus benefits)

Remote (USA)

The Role

As a result of our continued expansion, we are seeking a Director of Clinical Solution Design to lead our global team designing and customising clinical solutions for electronic Clinical Outcome Assessments (eCOA).

What will you do?

You will work closely with cross-functional teams, including product development, R&D, and sales, to ensure that eCOA solutions align with client needs, regulatory requirements, and industry standards.

Core components of the role will include:

Leadership and Strategy

  • Developing and leading the solution design strategy for the eCOA platform, ensuring alignment with clinical trial objectives and regulatory requirements.
  • Managing and mentoring a team of solution designers and clinical experts to deliver high-quality eCOA solutions.
  • Collaborating with executive leadership to define business objectives, KPIs, and long-term strategies for the eCOA business unit.

Client Engagement & Solution Design
  • Serving as the primary point of contact for clients during the solution design phase of eCOA projects.
  • Leading workshops and discovery sessions with clients to understand clinical trial needs and translate them into tailored eCOA solutions.
  • Designing and customizing eCOA solutions, including data capture workflows, protocols, and patient engagement strategies, to support clinical outcomes.

Cross-functional Collaboration
  • Partnering with product development and engineering teams to ensure that designed solutions are feasible, scalable, and aligned with the eCOA platform's capabilities.
  • Working with clinical operations and regulatory teams to ensure that eCOA solutions meet compliance standards for clinical trials.

Process Improvement and Innovation
  • Continuously evaluating and improving solution design processes to enhance efficiency and quality.
  • Staying informed of industry trends, emerging technologies, and regulatory changes to innovate and evolve the eCOA solutions offered by the company.

Quality Assurance and Compliance
  • Ensuring that all eCOA solutions adhere to GCP, GDPR, and other relevant regulatory frameworks.
  • Leading quality assurance efforts to validate that eCOA systems and processes are designed to ensure accuracy, reliability, and security of clinical data.

What you need to succeed

The ideal candidate will have deep expertise in clinical research, eCOA technologies, and a proven ability to lead solution design for complex clinical trials.

Essential Skills

  • Bachelor’s degree in Life Sciences, Health Informatics, or a related field; Master’s degree preferred.
  • Minimum of 7-10 years of experience in clinical trial operations, clinical research, or eCOA/ePRO.
  • Proven experience in designing and implementing clinical technology solutions for complex global clinical trials.
  • Strong understanding of regulatory guidelines such as FDA, EMA, ICH-GCP, and GDPR.
  • Excellent communication, leadership, and project management skills.
  • Experience with eCOA platforms, data management, and clinical trial design.

Essential Competencies
  • Strong problem-solving and analytical skills, with the ability to think strategically and act tactically.
  • Expertise in clinical trial design, protocol development, and regulatory requirements.
  • Proven ability to manage large, complex projects across multiple stakeholders and departments.
  • Experience working in a client-facing role, with excellent interpersonal and communication skills.
  • Knowledge of industry best practices for eCOA, patient-reported outcomes, and clinical outcome assessments.

uMotif is an equal opportunity employer

We positively encourage applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

We want everyone at uMotif to be comfortable bringing their true self to work.

That means acknowledging your personality, including the quirky bits, and bringing your interests, hopes, dreams, and even fears with you is fine, even if they don't seem relevant to your work.

Apply

Job Profile

Regions

North America

Countries

United States

Tasks
  • Collaborate with leadership
  • Design and customize solutions
  • Engage clients
  • Ensure compliance
  • Ensure quality assurance
  • Improve processes
  • Lead solution design strategy
  • Manage and mentor team
  • Quality assurance
Skills

Analytical Client Engagement Clinical Research Clinical Trial Design Clinical trial operations Data Management ECOA technologies EMA FDA GCP GDPR ICH GCP Interpersonal Process Improvement Project Management Protocol Development Quality Assurance Regulatory Guidelines Solution Design Strategic Thinking

Experience

7-10 years

Education

Bachelor's degree Master's degree

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9