Manager, Site Management & Monitoring (CRA Manager) - Remote
Job Highlights:
- Company: Workwarp
- Compensation: a competitive salary
- Start Date: Immediate openings available
- Location: Remote
- Position: Manager, Site Management & Monitoring- Remote
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Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and itÂs no small feat. It takes the imagination and passion of all of usÂfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearÂto look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which youÂll be supported to learn, grow and become your best self. Become a maker of possible with us. Position Summary The Manager, Site Management Essential / Key Job Responsibilities (including Supervisory And/or Fiscal)- Perform direct functional line management for the Site Management
- Manage the quality and consistency of site management
- Allocate resources to ensure proper workload distribution and site management and monitoring for ongoing projects and initiatives.
- Procure and provide oversight for external site management
- Ensure that site management
- Develop and oversee site management
- Provide guidance, lead training assignments, identify training opportunities and resolve readiness of site management
- Conduct, attend, or support co-monitoring visits, as needed, to evaluate internal
- Coach and ensure successful relationships between site management
- Review and prepare (as needed) study-specific site management
- Provide feedback on other clinical study documents, as needed, and serve as a resource for the BDPI Clinical Affairs team to facilitate a deeper understanding of site management
- Provide critical thinking and leadership support for issue escalation related to site management
- Provide strategic direction as a subject matter expert in the assessment of relevant new technologies and global clinical procedures, as applicable.
- Provide support and allocate resources for internal or external audits/inspections and ensure resolution of audit/inspection findings related to site management
- Review/approve expenses for site management
- Support continuous improvement activities/initiatives and sharing of standard processes, including development of site management
- Excellent working knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
- Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
- Advanced knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
- Excellent interpersonal and communication (oral and written) skills
- Excellent organizational skills, attention to detail, critical thinking and analytical skills
- Able to manage and delegate multiple tasks and prioritize importance of tasks/projects
- Ability to travel up to 25% (or more during peak times)
- Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease and/or oncology
- Proficiency with Veeva Vault CTMS, CDMS and eTMF
- Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)
- BachelorÂs Degree (BS/BA) or equivalent combination of training and experience
- 7+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
- 5+ years of experience with site management
- 3+ years of experience with people management (direct or indirect)
- Experience with medical device studies
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We Encourage You to Apply!
Even if you feel you're not a perfect match, we'd still love to hear from you. We are looking for great people to join our friendly team.
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