Senior eClinical Business Lead, IRT & DHT Design Consultant
New
J
JobgetherClinical Research
Remote work opportunity based in India.Full-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- GCP
Requirements
- 5+ years of experience building RTSM and/or DHT clinical trial systems, including requirements gathering, configuration, design, and user acceptance testing.
- Strong technical knowledge of clinical trial data standards.
- Experience applying data standards within clinical research environments (CDISC SDTM knowledge is preferred).
- Ability to create, document, and communicate business processes and train stakeholders.
- Strong analytical, problem-solving, and root cause analysis skills.
- Ability to independently resolve issues, apply sound judgment, and escalate when appropriate.
- Client-focused mindset with the ability to build and maintain trusted relationships.
- Knowledge of ICH and GCP regulations across relevant regions.
- Strong leadership skills with the ability to prioritize tasks and manage workload effectively.
- Excellent interpersonal, written, and verbal communication skills.
- Deep understanding of clinical research processes, clinical technologies, RTSM design, and system requirements.
- Bachelor’s degree in Life Sciences, Computer Science, or a related field, or equivalent professional experience.
Responsibilities
- Advise project leaders and study team members on RTSM (Randomization and Trial Supply Management) and DHT (Digital Health Technology) study design.
- Review clinical protocols and collaborate with stakeholders to define, analyze, and validate user requirements.
- Identify potential risks related to RTSM and DHT design and recommend effective mitigation strategies.
- Translate complex technology requirements into clear information to support study team decision-making.
- Evaluate system integrations and identify potential functionality challenges.
- Collaborate with UAT teams to support testing activities and successful system implementation.
- Maintain awareness of evolving RTSM, DHT, and clinical trial technology trends.
- Engage with external clients to discuss study design, protocol requirements, and technology solutions.
- Apply knowledge of ICH guidelines and Good Clinical Practices (GCP).
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