Clinical Trial Manager
hace 6 días
We are seeking a highly experienced Clinical Trial Manager to join our team at IQVIA. As a key member of our global clinical operations team, you will be responsible for the management of clinical trials from start-up to close-out.
Key Responsibilities:
- Lead the Study Management Team and ensure regional/global clinical operations deliverables progress according to agreed-upon timelines and milestones.
- Interface with stakeholders, including internal and external functions, such as study responsible physicians, data managers, trial supply managers, CRO staff, vendor staff, and trial sites.
- Ensure inspection readiness through compliance with clinical research protocols, company standard operating procedures (SOPs), codes of good clinical practice (GCP), applicable regulations, and guidelines.
- Oversight of selected vendors and status of related deliverables.
- Review and approve assigned vendor invoices/spend.
- Monitor budgets and expenditures as expected per planned trial budget.
- Create and update trial-specific documents as required, including monitoring guidelines, informed consent forms, investigational medicinal product-related documentation, blinding plans, and country/site feasibility-related documents.
- Provide input into cross-functional documents, such as safety-related documents, protocol deviations, and issue escalation processes.
- Ensure creation of appropriate trial-specific training materials and requirements, making them available to regional/site/CRO staff and delivering training as needed.
- Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leaders, and clinical supplies units.
- Demonstrate deep knowledge of protocols and procedures and adequate therapeutic area knowledge.
About You
- You have 6-8 years of clinical trial management experience in the pharmaceutical industry or CRO, with specific therapeutic area experience.
- You hold a BS degree or equivalent in life sciences (e.g., biology, chemistry, biochemistry, nursing, pharmacy).
- You have a strong working knowledge of ICH-GCP, local laws, and regulations.
- You possess superior clinical research operational knowledge and a proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
- You have demonstrated effective leadership skills, including the ability to proactively drive the study management team through key stages of trials and delegation skills.
- You have experience and ability in coordinating global or regional teams in a virtual environment, with a proven ability to foster team productivity and cohesiveness.
- You are proficient in speaking and writing in English and have a strong understanding of local country languages.
What We Offer
- A competitive salary range of $120,000-$180,000 per year, depending on experience.
- A comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
- The opportunity to work with a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.
How to Apply
Please submit your resume and cover letter to apply for this exciting opportunity.
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