- 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
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Clinical Research Manager - Carlsbad, United States - Alphatec Spine
Description
Job Description
Job DescriptionAn ATEC Clinical Research Manager (CRM) supports the company's Clinical Research initiatives by managing the clinical research operations and successful execution of clinical studies and data collection efforts in partnership with our clinical practice partners. Specifically, the position is responsible for the management of research activities spanning from development of study documents, to site start-up and recruitment of study participants, collection and compilation of study data, assists with site data management and analysis oversight of site monitoring and reporting of site performance and adherence to protocols following Good Clinical Practices, and input toward the reporting of study results. In a team supervisory capacity, the CRM develops project budgets and operating procedures and documents, supervises in-house and field-based monitoring staff, and ensures that project milestones are met while managing adherence to approved budgets. The role collaborates closely with other members of the Clinical & Scientific Affairs department as well as product marketing and field representatives.
Essential Duties and Responsibilities
Requirements
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience
Bachelor's degree is required, with study or experience in a health science concentration preferred. Minimum 2 years direct experience in clinical management role, preferably in medical device (spine industry a plus), demonstrating knowledge of GCP and research processes.
Certificates, Licenses, Registrations
CCRP preferred
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
Salary Range
Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $110,000 to $135,000 Full-Time Annual Salary
