Clinical Research Director
hace 3 días
Job Overview:
The Medical Department at Iqvia is a dynamic team comprising a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Clinical Research Director plays a pivotal role in providing medical and scientific support to clinical research programs, study teams, and investigators. This position involves reviewing, advising, and leading potentially or awarded clinical research programs. As a key member of the project team, the Clinical Research Director functions in a matrix report structure, akin to other team members. The primary responsibility of the Clinical Research Director is to provide medical oversight for clinical trials by serving as a Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies.
Key Responsibilities:
• Serve as a project team member, providing medical and scientific input to clinical research programs, including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting
• Ensure medical activities run according to Good Clinical Practice (GCP) standards and operate with highest efficiency
• Establish and maintain a network of medical/scientific consultants
• Supervise and manage Medical Director activities
Clinical Activities:
• Interact with clients regarding drug development programs, study design, and protocol reviews
• Collaborate with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints
• Participate in team approach to develop statistical and data management sections of the protocol
• Review the final protocol for clinical, safety, and efficacy variables
• Provide project team training on protocol and/or therapeutic areas
• Assist team with developing criteria for investigator site selection and networking for potential investigators for study participation
• Participate in subject recruitment and retention activities, including individual calls to key opinion leaders, investigators, and site staff
• Present protocol and/or safety reporting information at investigator meetings
• Develop project medical monitoring plans as requested
• Provide on-call coverage for protocol queries and site support
About Iqvia:
Iqvia is a leading provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We empower our customers and partners to drive healthcare forward and enable better patient outcomes. If you are passionate about making a meaningful impact in the life sciences industry, consider joining our team as a Clinical Research Director - Oncology and Hematology Expert.
Salary Range:
$120,000 - $180,000 per annum, depending on experience and qualifications.
Benefits:
Iqvia offers a comprehensive benefits package, including health insurance, retirement savings plan, paid time off, and opportunities for professional growth and development.
Requirements:
To be successful as a Clinical Research Director, you will need to possess strong leadership skills, excellent communication abilities, and a deep understanding of clinical research principles. A minimum of 8 years of experience in clinical research, preferably in oncology and hematology, is required. A Doctoral degree in a relevant field, such as medicine, pharmacy, or biology, is also necessary. Familiarity with GCP regulations and a strong analytical mindset will serve you well in this role.
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