
Posted 15 days ago
e-Clinical Business Lead
Parexele-Clinical Business Lead
Requirements
Experience in clinical trials (CRO/Pharma), Experience with CTMS, EDMS, EDC, IVRS, Knowledge of ICH-GCP and 21 CFR Part 11, Knowledge of CDISC SDTM, Degree level education, Fluent English
Skills
Project Management
About the role
Responsibilities
- Lead the implementation of eClinical platforms for clinical trials, ensuring timely start-up and quality delivery.
- Serve as the primary point of contact for internal teams and external customers regarding study technology, data integrations, and requirements.
- Collaborate with Project Leaders and study team members to identify and mitigate risks related to system set-up and integrations.
- Analyze study protocols to create and review user requirements and integration needs.
- Interact with external clients to discuss technology modifications and provide proactive solutions.
- Maintain up-to-date knowledge of Parexel technology offerings and industry developments in clinical trial processes.
Requirements
- Proven experience in clinical trials within a CRO or Pharmaceutical environment.
- Hands-on experience with clinical trial systems including CTMS, EDMS, EDC, and IVRS.
- Strong knowledge of ICH-GCP and regulatory standards such as 21 CFR Part 11.
- Familiarity with data standards, specifically CDISC SDTM.
- Degree-level education.
- Fluent English communication skills (verbal and written).
- Strong project management skills and the ability to work to tight deadlines.
Benefits
- Competitive financial packages.
- Comprehensive training and professional development programs.
- Flexible work arrangements, including fully remote options.
- A supportive culture that values work/life balance and employee welfare.
About the Company
Parexel is a global leader in clinical research, dedicated to improving patient lives through innovative medical research. We offer a multinational working environment with a highly qualified and dynamic team, focusing on both professional excellence and employee well-being.
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Parexel · Romania
