Manager, Clinical Research

About This Role

Manage clinical research operations and staff, ensuring studies adhere to protocols and regulations. This role involves staff hiring, training, development, and active oversight of study conduct while maintaining quality and efficiency.

Responsibilities

• Identify and hire appropriate clinic staff, prepare annual reviews, and handle performance issues with HR assistance
• Oversee the training, mentoring, and career development of all clinic staff
• Understand requirements for all studies and communicate them to all involved personnel/departments
• Ensure study panelists meet protocol requirements by working closely with the recruiting manager
• Assist in clinic staff scheduling to ensure all studies are staffed appropriately
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures
• Oversee the clinic conduct of each study and/or delegate supervisors as needed
• Ensure supplies and equipment from clients are available for studies
• Identify and provide solutions to clinical trial issues and/or risks
• Ensure inventory of internal supplies is adequate for current and upcoming studies
• Contribute to the preparation of clinical protocols, amendments, informed consent forms, and other clinical research documents
• Identify, develop, and review company policies and procedures
• Work closely with sponsors and monitors during site qualification, monitoring, and auditing visits
• Identify areas of improvement, especially related to quality and efficiency, and implement solutions
• Understand the site's P&L and its impact on clinical operations
• Manage staff and resources while considering the P&L for the site

Requirements

• Bachelor's Degree
• 5+ years in Clinical Research
• Minimum of 4 years of Supervisory/Leader experience
• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment
• Ability to develop collaborative relationships with internal and external stakeholders
• Strong decision-making/analytical skills
• Proficiency with Microsoft Office applications
• Knowledge of GCP/CLP guidelines and Federal Regulations related to the conduct of clinical trials

Qualifications

• Bachelor's Degree, preferably in science
• 5+ years in Clinical Research, with a minimum of 4 years of Supervisory/Leader experience

Nice to Have

• Degree in science
• NIH training

Skills

* Required skills

Certifications