Clinical Trial Manager
hace 1 día
Clinical Trial Manager
As a Clinical Trial Manager at IQVIA, you will be responsible for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. You will lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed-upon timelines and milestones.
Key Responsibilities:
- Ensure compliance with applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and local regulatory requirements.
- Manage timely and accurate documentation and communication of trial progress.
- Act as primary contact for Country and Regional staff.
- Drive study compliance by maintaining and updating trial management systems.
- Contribute to patient understanding of protocol and patient safety by reviewing and managing site-specific informed consent forms.
Essential Requirements:
- BA/BS degree in a health or science-related field.
- 1 to 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, assigned protocols, and associated protocol-specific procedures.
- Strong IT skills in appropriate software and company systems.
- Effective leadership skills and ability to manage multiple stakeholders.
- Proficient in speaking and writing the country language and English.
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