Senior eClinical Business Lead, IRT & DHT Design Consultant
Primary Location: India, Remote Job ID R0000043745 Category Administrative
About this Role
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.
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