Clinical Study Project Manager, Staff Clinical Scientist
- Full-Time
- New York, NY
- Beckman Coulter Diagnostics
- Posted 2 years ago – Accepting applications
Job Description
Wondering what’s within Beckman Coulter? Take a closer look.
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful!
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges!
The Clinical Study Project Manager (Staff Clinical Scientist) position for Beckman Coulter Diagnostics, provides an opportunity to combine your expertise in clinical research and our proprietary work processes to drive continuous process improvement. This role is part of the Clinical Decision Solutions Business unit and is a remote role. Travel, though now restricted, will be required, up to 35%. This individual facilitates maintaining and growing the product portfolio by generating clinical evidence to support product registration, post-market reporting, and marketing strategy.
You'll be a member of the Quality, Regulatory, Clinical Affairs team and report to the Sr Director, Quality, Regulatory and Clinical Affairs working on a cross-functional project core team. Accountability for development and execution of Product Evidence Strategy plan, a Global Clinical plan and effectively negotiate with government regulatory agencies, FDA.
In this role you’ll have the opportunity to:
Lead operational aspects within a clinical study team of clinical operations, biostatistics, and data management specialists to complete key clinical outputs
Plan and implement IRB submissions, site qualification, investigator qualification, site initiation, monitoring and close out activities in compliance with GCP and all applicable federal regulations.
Drive the conduct of the study (track status, maintain study files (e.g. TMF) coordinates forecasts, progress and mitigation plans to ensure all study operational aspects are on track and develops and performs risk mitigation plans.
Ensure data collection (or recruitment) targets are met and reviews enrollment at the site level including responsibility for approval of enrolling above site targets.
Coordinate and deliver all required trainings to investigators and clinical study team members.
Supervise the status of site budget and deliverables based on milestone payments.
Collaborate with legal in drafting MSAs, CRAs, SOWs, CDAs relating to clinical study activities.
Produces compliant high-quality clinical activity reports, and clinical study reports in collaboration with biostats, data science, regulatory, medical writing, and clinical leadership. The essential requirements of the job include:
Bachelor’s degree with 9+ years’ relevant clinical studies' experience, or Master’s with 7+ years’ experience, or Doctoral degree with 4+ years of experience.
Experience developing, organizing, and conducting complex multicenter global clinical trials for medical devices or deep technical knowledge of In-Vitro Diagnostic product development.
Direct experience in characterization, verification or clinical validation testing at external sites
Experience reviewing and summarizing clinical data analyses for study reports and publication
It would be a plus if you possess previous experience in:
Medical device or pharmaceutical experience in cardiac, hepatic, thyroid, reproductive disease
Experience working with Real World Evidence highly preferred
Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Apply to this Job
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful!
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges!
The Clinical Study Project Manager (Staff Clinical Scientist) position for Beckman Coulter Diagnostics, provides an opportunity to combine your expertise in clinical research and our proprietary work processes to drive continuous process improvement. This role is part of the Clinical Decision Solutions Business unit and is a remote role. Travel, though now restricted, will be required, up to 35%. This individual facilitates maintaining and growing the product portfolio by generating clinical evidence to support product registration, post-market reporting, and marketing strategy.
You'll be a member of the Quality, Regulatory, Clinical Affairs team and report to the Sr Director, Quality, Regulatory and Clinical Affairs working on a cross-functional project core team. Accountability for development and execution of Product Evidence Strategy plan, a Global Clinical plan and effectively negotiate with government regulatory agencies, FDA.
In this role you’ll have the opportunity to:
Lead operational aspects within a clinical study team of clinical operations, biostatistics, and data management specialists to complete key clinical outputs
Plan and implement IRB submissions, site qualification, investigator qualification, site initiation, monitoring and close out activities in compliance with GCP and all applicable federal regulations.
Drive the conduct of the study (track status, maintain study files (e.g. TMF) coordinates forecasts, progress and mitigation plans to ensure all study operational aspects are on track and develops and performs risk mitigation plans.
Ensure data collection (or recruitment) targets are met and reviews enrollment at the site level including responsibility for approval of enrolling above site targets.
Coordinate and deliver all required trainings to investigators and clinical study team members.
Supervise the status of site budget and deliverables based on milestone payments.
Collaborate with legal in drafting MSAs, CRAs, SOWs, CDAs relating to clinical study activities.
Produces compliant high-quality clinical activity reports, and clinical study reports in collaboration with biostats, data science, regulatory, medical writing, and clinical leadership. The essential requirements of the job include:
Bachelor’s degree with 9+ years’ relevant clinical studies' experience, or Master’s with 7+ years’ experience, or Doctoral degree with 4+ years of experience.
Experience developing, organizing, and conducting complex multicenter global clinical trials for medical devices or deep technical knowledge of In-Vitro Diagnostic product development.
Direct experience in characterization, verification or clinical validation testing at external sites
Experience reviewing and summarizing clinical data analyses for study reports and publication
It would be a plus if you possess previous experience in:
Medical device or pharmaceutical experience in cardiac, hepatic, thyroid, reproductive disease
Experience working with Real World Evidence highly preferred
Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.