Medical affairs Jobs in Wilmington, NC

We are seeking a highly experienced Senior / Medical Director, Neuroscience with a focus on Psychiatry to join a prestigious CRO. This role is central to ensuring the success and compliance of clinical trials, advancing research in psychiatric disorders, and upholding the highest standards of patient safety and data integrity.

Key Responsibilities

• Patient Safety and Ethics : Ensure the safety, rights, and well-being of study participants, upholding ethical and regulatory standards.
• Medical Monitoring : Oversee safety and efficacy data reviews, assess adverse events and serious adverse events, and analyze clinical data to identify trends, safety signals, and study outcomes.
• Protocol Development : Collaborate with cross-functional teams to design clinical trial protocols, informed consent forms, and case report forms.
• Regulatory Compliance : Ensure clinical activities adhere to ICH-GCP, FDA regulations, and other applicable standards.
• Team Collaboration : Partner with sponsors, clinical sites, project managers, regulatory teams, and statisticians to ensure smooth trial operations.
• Training and Support : Provide training to study staff on psychiatric assessments, safety monitoring, and adverse event reporting.

Qualifications

Preferred Qualifications

Seniority level

Director

Employment type

Full-time

Job function

Research

Industries

Pharmaceutical Manufacturing and Research Services

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