Associate Clinical Project Manager
On-site · Tempe, Arizona, United States
Job Summary
Associate Clinical Project Manager responsible for managing quality and compliance of assigned clinical projects per BD global procedures and GCP. Collaborates with cross-functional teams (R&D, Marketing, Quality) to define and execute clinical strategies, oversees project planning and budgeting, develops and maintains essential study documents (CIPs, ICFs, IBs, CRFs, CIRs), and contributes to regulatory submissions and product launches. Provides regular metric reports to Clinical Affairs leadership, supports audits/inspections, and ensures audit-ready TMF/CTMS/CDMS processes. Requires a Bachelor’s degree in life sciences and 3+ years of clinical research experience, with strong knowledge of GCP, regulatory requirements, and proficiency in Microsoft Office tools; travel up to 40%.
Required Qualifications
- Bachelor’s Degree (BS/BA) in life sciences
- 3+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
- 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.)
- Strong interpersonal and communication (oral and written) skills
- Strong organizational skills, attention to detail, critical thinking and analytical skills
- Ability to manage and delegate multiple tasks and prioritize importance of tasks/projects
- Ability to understand and interpret technical, scientific, and clinical information as it applies to product approval activities
- Ability to lead teams to translate issues into actions, make decisions and influence outcomes
- Ability to travel up to 40% (or more during peak times)
- Preferred: experience with medical device studies and CTMS/CDMS/eTMF systems (e.g., Veeva Vault)
- Professional certification through associations (e.g., ACRP, SOCRA) is a plus
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