Clinical Trial Operations Lead
hace 6 horas
Job Summary:
Clinical Trial Manager provides regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials.
About the Role:
The successful candidate will lead the Study Management Team (SMT) to ensure regional/global clinical operations deliverables progress according to agreed-upon timelines and milestones. Responsibilities include country & site feasibility, trial set-up, trial execution, and trial closure as well as vendor set up activities assigned by the Global Clinical Development Operations Trial Leader (GTL).
Key Responsibilities:
- Ensure services rendered adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
- Manage timely and accurate documentation and communication of trial progress.
- Act as primary contact for Country and Regional staff.
- Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
- Drive study compliance by maintaining and updating trial management systems.
- Contribute to patient understanding of protocol and patient safety by reviewing country-specific informed consent forms.
Requirements:
- Bachelor's degree in a health or science-related field.
- 1-8 years of clinical trial management experience in the pharmaceutical industry or CRO.
- Superior clinical research operational knowledge.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations.
- Effective leadership skills and ability to manage multiple stakeholders.
Salary Range: $120,000 - $180,000 per year
IQVIA Overview:
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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