Job Overview
Join our esteemed organization as a Clinical Research Manager, where you will be instrumental in the strategic planning, execution, and oversight of clinical trials aimed at evaluating the safety and efficacy of pioneering medical devices and tissue products. This pivotal role entails managing comprehensive clinical study activities from inception to report completion, ensuring strict adherence to FDA regulations, ISO standards, and other relevant guidelines.
Key Responsibilities
- Establish and oversee clinical study projects, including project planning and study design.
- Collaborate effectively with Contract Research Organizations (CROs) and cross-functional teams to create and execute strategic plans that align with study goals.
- Ensure seamless communication among clinical team members regarding vital activities for successful study execution and regulatory submissions.
- Contribute to the formulation of essential clinical documents, including protocols and informed consent forms.
- Prepare and submit documentation to Institutional Review Boards (IRBs) for approval while maintaining compliance with reporting obligations throughout the study.
- Train clinical investigators and staff on data collection and regulatory reporting requirements.
- Guarantee adherence to investigational plans, regulatory standards, and company policies throughout all clinical studies.
- Support data management processes, including the development and implementation of electronic data capture systems.
- Manage documentation, ensuring proper execution and archiving of all necessary agreements and records.
- Prepare status reports in accordance with federal reporting requirements for regulatory agencies and senior management.
- Develop and revise clinical-specific procedures to uphold compliance with evolving regulations.
- Provide assistance to Regulatory Affairs with necessary filings and registrations.
- Complete additional tasks as assigned, prioritizing punctuality and fulfillment of responsibilities.
Required Skills
- Proven ability to work both independently and collaboratively within cross-functional teams while adeptly managing multiple priorities.
- In-depth knowledge of Good Clinical Practices (GCPs), FDA regulations, and IRB requirements.
- Exceptional project management skills with an emphasis on quality and meticulous attention to detail.
- Strong verbal and written communication skills, capable of engaging effectively with all organizational levels and external partners.
- Familiarity with medical and anatomical terminology.
- Strong analytical capabilities to interpret technical procedures and regulatory guidelines, along with proficiency in report writing.
- Competence in desktop applications, including Microsoft Office and experience with electronic data capture (EDC) systems.
- Willingness to travel occasionally (less than 10%).
Qualifications
- A Bachelor's degree in biological science or a related discipline is required; an advanced degree is preferred.
- A minimum of 5 years of relevant clinical research experience, particularly with significant risk and non-significant risk IDE trials.
- Demonstrated ability to effectively interface with physicians and clinical staff in clinical settings.
Career Growth Opportunities
This role offers substantial opportunities for professional development, including the chance to enhance your expertise in clinical research and regulatory practices through training and collaboration.
Company Culture And Values
We pride ourselves on fostering a collaborative and supportive work environment that emphasizes compliance and high standards, reflecting our commitment to excellence in clinical research.
Employment Type: Full-Time