The clinical research manager is responsible for managing the clinical research department and overseeing clinical research studies. Individuals in this position provide direction to clinical research associates on the development, management, and completion of clinical research studies. The clinical research manager is also responsible for quality assurance, compliance with regulations, proper documentation, and budgeting for the department. Training and recruitment of employees for this department may be performed by the clinical research manager as well.
Additionally, individuals in this position may act as a liaison among the research staff, principal investigators, study participants, and research sponsors. The clinical research manager may also assist with recruitment of study participants and principal investigators. They generally work in a laboratory and office setting and report to the clinical operations manager and the associate director of clinical operations. Local and out-of-town travel may be required, but generally in small amounts.
Prospective clinical research managers generally need at least a bachelor’s degree in a biological science- or health-related field, as well as at least three to five years of clinical management experience. Knowledge of Pharm-Olam standard operating procedures, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/ Good Clinical Practice (ICH/GCP) requirements, and Food and Drug Administration (FDA) regulations are required, as are certifications in the appropriate clinical research areas. The clinical research manager position also requires excellent organizational and communication skills, as well as leadership skills, good attention to detail, effective problem solving abilities, and excellent interpersonal skills are a must.
Clinical Research Manager Tasks
Review, approve and oversee study budgets, contracts, regulatory and administrative documents.
Develop timelines and negotiate deliverables to ensure a timely, on-budget study.
Supervise, train and develop study team.
Analyze and develop study protocols to establish best clinical practice.
Work closely with other departments to ensure efficiency within the clinical trial.