Manager, Clinical Research

Job Description

• Identification and hiring of appropriate clinic staff, preparation of annual reviews and handing of performance issues, if any, with the assistance of the Human Resources Manager
• Oversees the training, mentoring and career development of all clinic staff
• Understands requirements for all studies and communicates to all personnel/departments involved in each study
• Works closely with recruiting manager to ensure study panelists meet protocol requirements
• Assists in clinic staff scheduling to ensure all studies are staffed appropriately
• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures
• Oversees the clinic conduct of each study and/or delegates supervisors to oversee when unavailable
• Ensures that supplies and equipment needed from clients are available for studies as necessary
• Identifies and provides solutions to clinical trial issues and/or risks
• Ensures inventory of internal supplies needed for studies is at a level to support current and upcoming studies
• Contributes to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
• Identifies, develops, and reviews company policies and procedures
• Works closely with sponsor’s and monitors during site qualification, monitoring, and auditing visits
• Identifies areas of improvement, especially related to quality and efficiency, and implements solutions
• Understanding of the site's P&L and how clincal operations can impact the P&L
• Manages staff and resources while considering the P&L for the site

Qualifications

• Bachelor's Degree, preferably in science
• 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, NIH training and CCRC/CCRA certification a strong plus