Job Description Summary

Associate Clinical Project Manager / Senior CRA collaborates with the core tea, clinical and medical affairs associates supporting the phases of product development and clinical evaluation of the product performance. This role supports Clinical Project Manager to complete activities related to clinical studies for ethics review, regulatory submissions and site management/monitoring.

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 it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to 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 you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

BD is searching an exceptional candidate to join our team! The role of the Associate Clinical Project Manager/Senior Research Associate is to support the execution and completion of assigned clinical research studies. The position will work under the lead Clinical Project Manager or Associate Director depending on the role assigned for the specific project. They may be responsible for the coordination and management of all aspects of clinical trial conduct including (but not limited to): study start-up activities; ongoing site management and monitoring; communication and documentation of key achievements and events; and study close out. This role will also provide administrative and project management support as needed.

We are based in Milpitas CA and prefer local individuals willing to commute in a Hybrid model, however we are open to fully remote work from anywhere in the US for highly qualified candidates.

Responsibilities

• Provide direct project management support for assigned protocols, developing and maintaining project plans, study timelines and study budgets.

• Coordinate and schedule various tasks throughout the study, such as participant enrollment, visits, shipments, etc.

• Communicate effectively with investigators and external partners.

• Monitor and manage study sites and Trial Master File accuracy and completeness for assigned studies

• Work cross functionally with other departments to ensure successful execution and oversight of clinical research studies.

• Obtain and track essential documents and approvals for study conduct.

• Maintain accurate and consistent electronic case report forms in appropriate systems.

Minimum Qualifications:

• Bachelor’s degree required.

• 5+ years relevant experience of direct field monitoring, site coordination and/or clinical research

• Knowledge of ICH/GCP principles and FDA regulations

• Experience with EMR, EDC, CTMS, and eTMF

• Excellent organizational skills and attention to detail.

• Strong written and verbal communication skills.

• Ability to manage multiple competing priorities simultaneously.

• Able to work independently and as part of a team environment.

• Must have excellent interpersonal skills to communicate with all levels within the organization.

Preferred Qualifications:

• Master’s degree preferred.

• Experience with flow cytometric analysis.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions