When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities
Project Delivery
Provide consultation to Project Leaders and other study team members on RTSM and DHT (Digital Health Technology) study design.
Analyze protocols and collaborate with all stakeholders to create and review user Requirements and ensure they meet the needs of the study design.
Identify and mitigate any risks related to RTSM and DHT study design.
Translate complex RTSM and DHT requirement descriptions into language that can be understood by study team to aid in their decision making and understanding of project functionality.
Understand the various integrations that can interface with RTSM and DHT and proactively help identify any potential integration user requirements issues.
Work closely with UAT Leads.
Stay current on RTSM and DHT technology and relevant clinical trial process developments in the industry and requirements within Parexel.
Manage quality control and timely delivery of project deliverables and appropriate remedial action.
Client Management
Interact with external clients as needed for discussion on RTSM and DHT design and protocol elements.
Demonstrate a proactive approach to providing solutions in a timely manner.
General Administration
Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices.
Complete routine administrative tasks in a timely manner (e.g., timesheets, training) and in compliance with relevant guidelines.
Skills and Experience
5+ years of experience in building RTSM and/or DHT clinical trial systems and developing user requirement with detailed understanding of requirements gathering, configuration, design, and user acceptance testing.
Excellent technical and data standard experience.
Proven awareness and experience in the use of data standards within a clinical trial environment; knowledge of industry standards such as CDISC SDTM is preferred.
Ability to create and explain business process and train others on that process.
Strong analytical and problem-solving skills.
Ability to resolve issues independently with good judgement to escalate appropriately.
Client focused and demonstrating an ability to create and maintain trust with the client.
Knowledgeable in ICH and GCP regulations in relevant geographies.
Personal leadership, prioritization and management of own workload.
Ability to conduct root cause analysis in business problem solving and process improvement development.
Excellent interpersonal, verbal, and written communication skills.
Knowledge in clinical research industry, including expert understanding of clinical technology, RTSM design, and system requirements.
eCOA, ePRO experience is a plus.
Education
Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent experience.
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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