Solution Design Analyst
Studion
full-time
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- Lead the configuration and deployment of clinical trial platforms: Oversee the end-to-end design, configuration, and implementation of digital platforms for clinical trials, ensuring they meet both client requirements and regulatory standards in accordance with Good Clinical Practice (GCP), 21 CFR Part 11, ICH E6(R3) and internal quality management procedures.
- Translate clinical protocols into actionable system configurations: Work closely with clients to gather and understand complex clinical requirements, transforming them into precise system specifications.
- Collaborate with multidisciplinary teams: Coordinate with internal and client teams to ensure successful delivery of digital solutions, from initial planning to full deployment.
- Integrate connected devices and clinical systems: Utilize your experience with eCOA systems and other connected devices to ensure seamless integration with clinical systems and data management platforms.
- Provide expertise in clinical study design: Offer strategic guidance on optimizing clinical trial designs, ensuring they are both efficient and compliant with industry regulations.
- Manage project timelines and objectives: Develop and oversee comprehensive project plans, ensuring all milestones are met within the agreed timelines.
- Drive continuous process improvement: Continuously assess and improve the platform implementation process, proactively addressing potential challenges and optimizing client satisfaction.
- Support and educate clients: Provide training and ongoing support to clients, ensuring they fully understand and can effectively use the digital platforms.
Requirements
- At least 6 years of experience in developing and configuring digital solutions for clinical trials, including at least 3 years working specifically with eCOA systems.
- Strong understanding of clinical trial processes and regulations, particularly in relation to digital solution implementation and study design.
- Skilled at translating complex clinical requirements into clear, actionable technical specifications.
- Proven ability to manage senior stakeholders, with strong negotiation, collaboration, and leadership skills.
- Experienced in integrating connected devices (e.g., PEF, oxygen monitors) with broader clinical systems.
- Possesses strong analytical and problem-solving abilities, able to manage multiple projects in a fast-paced environment.
- Excellent verbal and written communication skills, capable of engaging effectively with both internal teams and external clients.
- Comfortable working both independently and within a collaborative team setting.
Benefits
- Health and dental insurance with Studion covering the majority of premiums, so you can access the care you need.
- Short-term disability, long-term disability, and life insurance to support you in unexpected situations.
- A wellness stipend to help you get — and stay — healthy.
- Flexible work hours and generous time off, so you can balance work with the things that matter most to you.
- A top-notch 401(k) to help you plan confidently for the future.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
configurationdeploymentdigital platformsclinical trial designeCOA systemssystem specificationsproject managementprocess improvementdata management
Soft Skills
negotiationcollaborationleadershipanalytical skillsproblem-solvingcommunicationclient supportindependent workteam collaboration
Certifications
Good Clinical Practice (GCP)21 CFR Part 11ICH E6(R3)