BIOTRONIK is looking to add a Manager, Clinical Research Group (CRA) to our Clinical Studies team. In this role you will manage the organizational and administrative aspects of BIOTRONIK Clinical Studies to ensure they are conducted in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures and IRB/EC policies and procedures) through the leadership and direction of the CRA group. The Manager, CRA Group collaborates with Clinical Studies Management and study teams to develop and drive risk-based monitoring plans and operational improvements.
- Develop and execute strategic and operational objectives for the Clinical Research Associate (CRA) Group through the creation and maintenance of GCP Standard Operating Procedures, Work Instructions and monitoring plans
- Lead and mentor the CRA Group conducting all aspects of Investigational Device Exemption, post-approval and post-market medical device studies. These responsibilities may include assisting with protocol, case report form, monitoring plan and electronic data capture system development; clinical report writing, investigational device inventory management; on-site and centralized monitoring; review and finalization of monitoring visits reports; and FDA report and approval submissions
- Monitor CRA Group compliance to Federal regulations, BIOTRONIK SOPs and monitoring plans through automated reporting and audits, and implement corrective and preventive action as necessary
- Collaborate with investigators to resolve non-compliance concerns and determine corrective and preventive actions
- Coordinate preparations and support of successful FDA inspections at sponsor and sites in response to FDA Pre-Market Approval submissions
- Oversee all study documentation from investigators and investigational sites to ensure that they meet FDA requirements and relevant BIOTRONIK SOPs.
- Assist in the writing/review of protocols, informed consent forms and monitoring plans
- Serve as a resource to Clinical Studies personnel, BIOTRONIK field personnel, site coordinators, investigators, and other staff members regarding clinical studies
- Conduct vendor audits as requested
- Interface with project teams to ensure that clinical studies are progressing according to plan, on track to meet study endpoints, and to achieve success through FDA approval
- Interface with sales department to ensure that clinical studies meet enrollment goals and satisfy compliance requirements
- Interface with Regulatory, Marketing, Advanced Product Support, Sales, and administrative staff as necessary to accomplish the above responsibilities
- Responsible for training and evaluation of CRAs and CPA staff
- Participates in the employee performance review process by providing timely and accurate feedback regarding the performance of each respective team member
- Bachelor’s or graduate degree in health profession, science and/or engineering field
- Minimum 5 years’ experience in the medical device or pharmaceutical industry in a CRA position or similar role.
- 1-2 years personnel management experience preferred.
- Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is required.
- Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials. Strong compliance focus.
- Demonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge.
- Excellent leadership skills and the ability to motivate others to work together to a common goal.
- Excellent communication skills and the ability to work with all levels of the company.
- Excellent computer skills and database management experience.
- Excellent organizational skills and attention to detail.
- Up to 25% travel is required for vendor audits, monitoring responsibilities, industry or regulatory agency meetings, and educational seminars.
To apply for this job please visit career012.successfactors.eu.