Manager, Clinical Operations (Office-Based) - NCR
The Manager, Clinical Operations is responsible for the conduct of large-scale, multi-center studies, both U.S. and international. Responsibilities include initial planning and preparation for the study; management of staff, and other logistic operations as required.
Key Job Responsibilities:
Manages all aspects of assigned clinical studies and associated risks to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
Manages clinical staff, including assigned in-house Clinical Research Associates (CRAs) and Clinical Trials Assistants (CTAs), and external contract resources.
Provides leadership for the operations of the clinical department (e.g., writes/reviews/revises SOPs, writes procedures, develops forms, develops databases, initiates contracts, reviews and negotiates clinical site budgets, trains staff).
Serves as key interface with external vendors, including RFP process, contract negotiation, and performance monitoring.
Provides leadership and guidance, clinical trial management expertise and direction to in-house and contract staff.
Prepares and/or assists in the preparation and oversight of study budgets and timelines.
Analyzes and develops action plans to address study conduct issues with investigational sites and/or CROs.
Provides input to the project team and project schedule in accordance with the integrated project plan.
Serves as key reviewer during clinical trial protocol development and CRF design.
Assists the Medical Monitor with site communications.
Analyzes/comments on safety, patient care, and study design and/or study conduct issues.
Forecasts 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), with an advanced degree in the discipline of life sciences or business a plus.
Minimum of 8 years of relevant clinical research experience, including at least 3 years of experience as a Clinical Trials Manager within the pharmaceutical or biotechnology industry.
Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
Proficiency in the implementation, monitoring and management of clinical trials, preferably in oncology.
Experience managing global studies a plus.
Demonstrated management and/or supervisory experience and experience managing investigational sites, contract staff and Clinical Research Organizations (CROs).
Broad knowledge and cross-functional understanding of clinical trial methodology.
Demonstrated proficiency in MS Office applications, including Project, Excel, Word, PowerPoint and Share Point.
Highly effective organizational skills, including the proven ability to communicate effectively with all levels and across all functions, both internal and external to the organization.
Exceptional written and verbal communication and presentation skills, including presenting to senior management.
Demonstrated leadership skills in a complex environment with changing project priorities, incorporating problem solving skills and requiring limited oversight.
Ability to work in a highly collaborative team environment.
Dedication to quality and reliability in all work tasks.
Self-motivated, eagerness to grow professionally and commitment to self-development.
Requires an ability and willingness for intermittent travel as necessary, consistent with the project needs.
EEO Minorities/Females/Protected Veterans/Disabled
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