Clinical Research Manager
Alphatec Spine
- Carlsbad, CA
- $110,000-135,000 per year
- Permanent
- Full-time
- Develops study documents, including: protocols - requiring an interest in and capacity to understand the study objectives, key variables, and logistical requirements; case report forms (CRFs) - requiring insights on flow and format of clinical data acquisition; participant consent forms and other regulatory documents - requiring knowledge of institutional review board (IRB) requirements and processes and good clinical practices (GCP)
- Supervises in-house and field-based Clinical Research Associates (monitors) in site selection, initiation, and close-out; oversees CRA's performance in liaising with site personnel to obtain, prepare, submit, and track local IRB review, contracting processes, and training of site personnel on study procedures
- Manages team toward the development of monitoring plans and procedures, the monitoring of site performance to study goals and adherence to study protocols, and the generation of monitoring reports to effectively communicate progress and/or issues to the site and internally to management
- Develops data collection and management plans, oversees this activity, and reports on study status
- Guides the generation and implementation of action plans and tools to support site needs and/or to overcome site challenges; works creatively and independently to ensure successful study objectives relative to enrollment and completion goals; examples may include generating strategies for subject recruitment, screening, and/or visit tracking tools
- Oversees and approves clinical data entry into databases, such as following receipt of hard-copy CRFs
- Manages the tracking and accrual of budgeted study activities and the processing of study payments based on site-specific contracts and documentation of data received
- Ensures that site participation is in compliance with all local and federal laws and regulations
- Identifies, negotiates, and manages vendor relationships
- Collaborates with other research personnel to generate factual and accurate output from study data, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral
- Performs other duties as required
- Superior problem-solving skills with a solid understanding of, and firsthand experience in, clinical research operations and the principles and processes of scientific data collection, analysis, and management methods
- Knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance ICH/GCP, US Code of Federal Regulations (CFR), and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki
- Superior organization skills, attention to detail, and the ability to keep detailed, accurate records
- Demonstrated ability to work collaboratively with multifunctional internal and external teams
- Excellent analytical and creative thinking skills
- Excellent oral and written communication skills
- Ability to travel extensively and on short-notice, and to independently manage travel schedule and logistics
- Ability to organize and prioritize workflow to meet established timeframes, while working in a fast-paced and goal-oriented environment
- Ability to work within a cross-functional team and matrix management structure
- Ability to exercise independent judgment consistent with department guidelines
- Ability to learn and maintain knowledge of procedures, products and activities of assigned area
- Proficiency with common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required
- Experience with electronic data collection systems a plus