Description
A biopharmaceutical company seeks an M.D. with a suitable background / experience in the industry to serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for clinical studies. Other responsibilities include, but not limited to:- Execute and supervise clinical studies, analyze results and write study reports.
- Contribute to the clinical sections of regulatory documents and meetings.
- Interact with regulatory agencies throughout the development process.
- Manage the drug development process from protocol creation thorough individual study report and integrated regulatory document creation.
- Collaborate with contributing groups such as Biostatistics, Drug Safety, Regulatory Affairs, Quality Assurance, Project Planning, and Clinical & Medical Affairs, etc.
- Consult with key opinion leaders, as needed, to ensure drug development activities are in line with current medical knowledge and standards.
- Collaborate with external contract service vendors, Investigators, and clinicians.
Requirements
- Doctoral degree (MD, DO, PhD, PharmD, etc) is required
- Experience and expertise in creating and implementing drug development strategies resulting in efficient and successful product approvals; minimum 3 years required
- Expertise in the regulations and guidance (CFR, ICH, GCP) governing drug development.
- Expertise in clinical study monitoring, eg, assessing adverse events, safety lab test results, ECGs, etc.
- Expertise in the clinical drug development process is required. Effective leader of clinical research staff. Exceptional interpersonal skills.
- Expertise in assuring high-quality clinical trial conduct management, data management, and data analysis.
- Expertise in problem solving for addressing clinical and conduct issues that may occur during study management.
- Comfortable working in a fast-paced, matrix pharmaceutical company.
- Excellent oral and written communication skills. Expert with Microsoft Office programs.
To find out more about Real please visit www.realstaffing.com