Clinical Project Manager - Remote

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At first glance, you will see that for more than 80 years we have 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 are building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you will 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 are working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time!

The Clinical Project Manager represents the clinical function on the product development core team and is responsible for driving core deliverables such as Clinical Evidence Strategy Planning, Protocol Design, and Development, as well as execution of Clinical Validation activities which may include biospecimen sample collection, as applicable.

The position provides an opportunity to combine your expertise in clinical research and integrate Danaher standard work processes to drive continuous process improvement and develop professionally. Along with professional experience in a medical or research setting, we are looking for someone who is process-oriented with excellent communication, interpersonal, and project management skills. If this describes you — read on.

The Clinical Project Manager position is part of the Clinical Affairs Department aligned with Chaska, MN, and this is a fully Remote role. You will report to the Sr. Manager of Clinical Affairs and be part of a cohesive, high-performing team.

In this role, you will have the opportunity to:

• Support clinical team on activities related to site activation, budget management, processing site compensation, supporting accruals, contract execution, collection and document retention of essential documentation, and vendor support activities.
• Partner with the data management team to effectively operate within the data management plan and data management procedures including the Laboratory Information Data Management System (LIDMS)
• Represent Clinical Affairs on a cross-functional New Product Development core team and responsible for the completion of clinical validation deliverables to support the phase gates (e.g., Clinical Protocol, Final Clinical Study Report).
• Accountable for the oversight to adhere PHI protection, GCP Good Clinical Practices (GCP) and Standard Operating Procedures, and investigational-use-only (IUO) product reconciliation activities.
• Drive clinical schedule deliverables to meet the overall project timelines, influencing internal and external partners to support on-time delivery through relationship management skills.

The essential requirements of the job include:

• Demonstrated agility with processes and details, ability to apply critical thinking, analyze data (using analytical tools), and solve complex problems.
• Ability to work independently and effectively in a fast-paced and changing environment.
• Bachelor’s Degree in the field with 9+ years of experience or a Master’s Degree with 7+ years of experience or Ph.D. degree with 4+ years of experience
• Proficiency in Microsoft Office applications (PowerPoint, Excel, Word)
• Knowledge and experience with GCP and global IVD medical device or pharmaceutical regulations

It would be a plus if you also possess previous experience in:

• Electronic data capture (EDC) system and eTMF system (Florence)
• Clinical research certification (i.e., SOCRA, CCRA, CCRC)
• Familiarity with cardiac biomarkers and heart failure
• CLSI guidelines and Good Laboratory Practice (GLP) experience

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

The salary range for this role is $120-135K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and it may be modified in the future.

This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.

If you’ve ever wondered what’s within you, there’s no better time to find out.