Clinical Project Manager
BD - Milpitas, CA
posted 4 months ago
About the position
The Clinical Project Manager (CPM) at BD Biosciences is responsible for independently managing all aspects of moderate to complex clinical performance studies in compliance with Good Clinical Practices (GCP) and applicable regulations. This role involves leading the planning and execution of in vitro diagnostic (IVD) clinical studies, ensuring that results are completed on time and within budget. The CPM will also provide or assist in providing Site Management and Monitoring support for studies, participating in cross-functional project teams to plan and execute successful clinical studies from concept through completion, in alignment with corporate objectives. The successful CPM will oversee the planning and execution of clinical studies, which includes developing clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents. They will also be responsible for developing clinical study reports for submission to regulatory authorities and tracking the clinical study budget, including invoice review and monthly accruals. The CPM will manage external vendors to ensure that deliverables are completed on time and within budget, while also ensuring compliance with BD policies, FDA regulations, ISO standards, and GCP. In addition to these responsibilities, the CPM will supervise department personnel as needed, create and maintain clinical study documents as part of the trial master file (TMF), and interact with investigational sites, vendors, key opinion leaders (KOLs), and consultants. The role requires the ability to effectively prioritize tasks and responsibilities, ensuring that project milestones are met or exceeded. The CPM will also be responsible for timely creation and maintenance of clinical study registration updates for studies conducted both in the United States and globally.
Responsibilities
- Oversee the planning and execution of clinical studies, including clinical study timeline development.
- Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents.
- Develop clinical study reports for submission to regulatory authorities.
- Develop and track the clinical study budget, including invoice review/approval and monthly accruals.
- Oversee and review deliverables produced by study team members to ensure quality and compliance.
- Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work.
- Ensure that studies comply with BD policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations.
- Demonstrate understanding of BD's general business functions, products, and procedures and serve on cross-functional project teams as a clinical subject matter expert.
- Develop and implement standardized processes and operating procedures for conducting clinical research.
- Supervise department personnel as needed.
- Create and maintain clinical study documents as part of the trial master file (TMF).
- Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants.
- Conduct on-site clinical monitoring activities as needed.
- Lead and actively participate in various cross functional team meetings.
- Ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded.
- Responsible for timely creation and maintenance of clinical study registration updates.
Requirements
- Five (5) or more years of experience in Clinical Research.
- Three (3) or more years of experience managing clinical research studies.
- Experience with Flow Cytometry is required.
- Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies.
- Ability to work independently, manage multiple projects and personnel in a fast-paced environment, and effectively navigate obstacles.
- Excellent communication skills (oral and written).
- Strong computer skills and proficiency with Microsoft Office Suite applications.
- Strong interpersonal and organizational skills.
- Ability to travel up to 30%.
Nice-to-haves
- Three (3) or more years of experience managing medical device studies.
- Previous experience managing or mentoring personnel.
- Previous site monitoring and/or CRA experience.
Benefits
- Competitive salary range of $126,600 - $208,900 annually.
- Hybrid work environment with flexibility to work from home up to 2 days a week.
- Opportunities for professional development and career growth.
- Supportive work culture that values contributions and encourages authenticity.
