Clinical Research Manager
What you will be doing:
- Responsible for setting the standard for the Clinical Affairs (CA) department on good monitoring practices and study documentation per Insightec SOPs/processes and ICH GCP.
- Responsible for training all CRA personnel on Insightec practices and procedures for study monitoring and study documentation
- Will administratively manage CRAs and CRAAs based out of Americas/ Dallas, assign projects, and ensure appropriate training for personnel is documented. May co- travel with monitors to ensure monitoring practices are being followed and/or assist monitors with addressing issues at sites, as needed
- Will ensure consistency in CRA/CRAA processes and practices across all geographies, consistent with local global regulations
- Will function as a resource within the global CA department for best practices and problem-solving monitoring/QA issues
- Will work with Director of Clinical Trials, GMO and Director of Clinical Research to create/review/ revise/update department SOPs, work instructions and processes to allow Insightec flexibility across all geographies based upon differences in local/global regulatory requirements
- Ensure trial activities are conducted, recorded, and reported in accordance with the protocols, applicable regulatory requirements, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) Identify and raise issues of significance to the appropriate level for resolution
- Assist in training of other Clinical Affairs personnel on Insightec practices and procedures for study monitoring and study documentation.
- Assist with QA and auditing procedures
- Lead/Assist in organizing documentation for regulatory submissions, including IDE and PMA FDA submission
- File all regulatory correspondence in the RMF
- Set up and maintenance of internal (central) Regulatory Master File
- Work closely with other CRAs for coverage in collecting and reviewing regulatory documentation and assuring consistency between RMF and site files.
- Generate and maintain study checklists as necessary and keeps accurate records of all essential study material(s).
- Responsible for accurate and timely oversight and maintenance of RMF.
- Demonstrated expertise in understanding and managing clinical study documentation.
- Proper and timely filing of all relevant study documents and standardized filing across all studies, per applicable SOPs.
What you have:
- Bachelor’s degree in a life science field
- At least 6 years relevant industry experience in clinical research environment
- Familiarity with medical terminology
- Formal GCP Certification required, CRA Certification preferred
- Basic computer skills with proficiency in Microsoft Word and Excel required, PowerPoint and Database experience desirable
- Ability to foster relationships with clinical sites and colleagues
- Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
- Able to work independently with excellent time management skills
- Approximately 50% travel that will vary over time, including limited international travel (able to travel abroad and obtain relevant visas)
Successful candidate(s) will be required to comply with Insightec’s Vaccination Policy.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender/gender identity, age, disability, marital status, sexual orientation, national origin, veteran status, and any other legally protected status entitled to protection under federal, state, or local anti-discrimination laws.
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エクサブレート・ニューロ（Exablate Neuro）は販売名「MRガイド下集束超音波治療器 ExAblate 4000」のことです。