Clinical Trials Manager (Office-Based) - NCR
The Clinical Trials Manager is responsible for managing operational logistics and conduct of clinical studies, including clinical sites, assigned personnel, and project teams.
Key Job Responsibilities:
Manages all aspects of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
Provides leadership role in the operations of the study teams (e.g., writes/reviews/revises SOPs, writes procedures, develops forms, reviews and negotiates clinical site budgets, trains staff).
Provides leadership and guidance, clinical trial management expertise and direction to in-house, contract, and vendor CRAs.
Reviews department budgets and timelines.
Analyzes and develops action plans to address administrative issues with investigational sites and/or CROs.
Oversees the design and development of clinical trial protocols and case report forms.
Assists the Medical Monitor with preparation of study reports.
Manages the activities of Contract Research Organizations.
Reports safety issues, patient care issues, and study design and/or study conduct issues.
Manages clinical supplies required for the conduct of clinical trials.
Develops/directs clinical monitoring plans and study monitoring priorities.
Performs other responsibilities as assigned.
Education / Experience / Professional Requirements:
Bachelor’s degree in a scientific discipline or health-related field (or equivalent).
Advanced degree in the discipline of life sciences or business is a plus.
Six or more years of relevant experience, including supervision of a study team. Must have at least five years of experience as a CRA in a pharmaceutical company.
Experience monitoring or overseeing monitoring activities in international studies a plus.
Demonstrated proficiency in the implementation, monitoring and management of clinical trials
Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
Demonstrated management and/or supervisory skills.
Broad knowledge and cross-functional understanding of clinical trial methodology.
Proficient in the use of modern management and communication tools.
Computer proficiency (PC-Windows preferred).
Clear and concise verbal and written communication skills.
Ability to manage investigational sites, contract personnel and CROs.
Strong organizational skills.
Ability to prioritize and handle multiple tasks simultaneously.
Ability to work independently and in a team environment.
Dedication to quality and reliability in all work tasks.
Self-motivated, eagerness to grow professionally and commitment to self-development.
Willingness to travel as necessary, consistent with the project needs.
EEO Minorities/Females/Protected Veterans/Disabled
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