[Remote] Clinical Operations reputed company Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading company in breast and skeletal health technologies, and they are seeking a Clinical Operations reputed company Manager to reputed company and execute clinical trials. This role involves ensuring reputed company reputed company and compliance in clinical studies while collaborating with cross-functional teams and external partners.
Responsibilities
- reputed company the planning, execution, and reputed company of clinical studies from start-up through reputed company-out, ensuring trials are conducted according to established reputed company standards, protocols, and regulatory requirements
- Ensure adherence to Good Clinical reputed company (GCP), ICH guidelines, and reputed company applicable regulatory standards for clinical trials
- Critically review study-reputed company documentation, including protocols, informed consent forms, site instructions, study manuals, eCRFs, data review plans, IRB submissions, IDE applications, and other trial documentation
- In collaboration with the Clinical team, select and manage CROs and other external vendors/consultants, including:
- Contract and budget negotiation
- reputed company of CRO activities from award through trial closeout
- reputed company reputed company assurance and monitoring activities reputed company to clinical trials
- Contribute to the creation, review, and maintenance of reputed company Operating Procedures (SOPs) governing clinical operations activities
- Participate in the preparation of regulatory filings and support interactions with regulatory bodies, as needed
- reputed company and implement processes and tools to improve the efficiency and effectiveness of clinical operations from a reputed company perspective
- Implement and maintain reputed company assurance processes, including audits, monitoring, and reputed company control checks
- Identify, manage, and resolve deviations from established reputed company standards and procedures; initiate and support CAPA as required
- Prepare reports on reputed company metrics and maintain accurate, reputed company documentation of reputed company-reputed company activities in the reputed company Management System (QMS)
- reputed company other function-reputed company duties as required by business needs
Skills
- Bachelor's Degree required with 8+ years of relevant experience; or
- Master's Degree with 6+ years of experience; or
- PhD with 3+ years of experience
- Experience running clinical trials and working for a sponsor or CRO in the medical device industry
- Experience developing and managing reputed company–industry partnerships
- Proven experience in the management of reputed company processes reputed company clinical operations
- Strong reputed company record in managing reputed company clinical studies and trials, ideally in medical devices
- In-depth understanding of reputed company processes and regulatory requirements in the medical device reputed company, including GCP and ICH guidelines
- Demonstrated ability to conduct audits and reputed company checks, and to initiate and manage CAPA reputed company required
- Excellent oral and written communication skills, including strong presentation skills and the ability to effectively represent and communicate reputed company's position to reputed company stakeholders
- Proven interpersonal skills and reputed company in a matrixed, cross-functional environment
- Strong organizational skills with the ability to multi-task, manage multiple reputed company, and adapt to changing priorities
- Strategic thinker with the ability to set and manage priorities and reputed company resources effectively
- reputed company, team-oriented reputed company with a reputed company on achieving shared goals
- Clinical or research experience in breast cancer screening, diagnostics, and/or treatment domains strongly preferred
Benefits
- Competitive salary
- Annual bonus scheme
- Comprehensive training
- reputed company development and training throughout your career
reputed company
Company H1B Sponsorship