CloudHire
Website:
cloudhire.ai
Job details:
Position Overview
We are looking for a professional with experience in clinical research, real-world evidence (RWE), epidemiology, HEOR, or related study operations to support the successful execution of non-interventional and late-phase RWE studies. The role involves managing study operations, coordinating with vendors and stakeholders, ensuring regulatory compliance, and delivering high-quality study outcomes across global projects.
Key Responsibilities
- Manage the end-to-end delivery of non-interventional or late-phase RWE studies, including protocols, data acquisition, and vendor oversight.
- Coordinate with CROs, data providers, and analytics partners to ensure timely project delivery and high-quality outputs.
- Lead vendor management activities including RFP development, contracting, and deliverable oversight.
- Develop and maintain project plans, risk registers, timelines, and budgets.
- Ensure compliance with GCP guidelines, ethical standards, and data privacy regulations.
- Support the acquisition and operational management of RWE data sources such as claims data, EHRs, registries, and patient-reported outcomes (PROs).
- Manage stakeholder relationships and ensure effective communication, issue escalation, and resolution throughout the project lifecycle.
- Contribute to inspection readiness and study documentation, including maintenance of the Trial Master File (TMF).
- Collaborate with cross-functional teams to ensure smooth execution of global, multi-country studies.
Required Skills
- Strong knowledge of real-world evidence (RWE) study operations.
- Experience with clinical research processes and non-interventional studies.
- Strong project management and stakeholder management skills.
- Experience working with multiple vendors and cross-functional teams.
- Understanding of regulatory frameworks and data privacy requirements (e.g., GDPR).
- Strong analytical and problem-solving abilities.
- Excellent communication and coordination skills.
Experience
- 3–5 years of experience in clinical research, real-world evidence (RWE), epidemiology, HEOR, or related study operations.
- Experience managing end-to-end delivery of RWE studies, including protocols, data acquisition, and vendor management.
- Experience working with CROs, data providers, and analytics partners.
- Exposure to global or multi-country study operations is preferred.
Mandatory Requirements
- Strong command of English (written and spoken); additional languages are a plus depending on the hiring region.
- Demonstrated ability to manage project timelines, budgets, and risk management processes.
- Strong experience in stakeholder engagement and issue resolution.
- Working knowledge of RWE data sources such as claims data, EHR, registries, and PROs.
- Demonstrated commitment to GCP compliance, ethical guidelines, and data privacy regulations.
- Authorization to work in the hiring country (where applicable).
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