Solution Design Analyst
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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. • We recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence. Therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodations during the interview process.
Responsibilities
• 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.
Benefits
• We know that the right benefits and perks enable team members to do their best work and live their best lives. We take a holistic approach to total rewards, focusing on what truly matters. • Fair and competitive compensation that reflects the role, relevant experience, and local market conditions. Most candidates can expect offers to be positioned within the middle of the range, with placement determined by experience, skills, and role alignment. Compensation details will be shared during the hiring process and provided upon request, in accordance with applicable law. • 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.