Senior CRA/Associate Clinical Project Manager at BD (Becton, Dickinson and Company) Milpitas, CA

BD (Becton, Dickinson and Company); Milpitas (CA); On-site; USD 92,700 - 152,900; Full time

Job summary

BD (Becton, Dickinson and Company) is looking for a Senior CRA/Associate Clinical Project Manager in Milpitas, CA. The position entails managing clinical studies, supporting project plans and participant coordination.

The ideal candidate should have a Bachelor's degree, 5+ years of experience in clinical research, and knowledge of FDA regulations. This role offers a hybrid work model and a competitive salary.

Qualifications

• 5+ years relevant experience of direct field monitoring, site coordination and/or clinical research.
• Knowledge of ICH/GCP principles and FDA regulations.
• Ability to manage multiple competing priorities simultaneously.

Responsibilities

• Provide direct project management support for assigned protocols.
• Monitor and manage study sites and Trial Master File accuracy.
• Work cross functionally with other departments.

Skills

Field monitoring

Site coordination

Clinical research

Organizational skills

Communication skills

Education

Bachelor's degree

Master's degree preferred

Tools

EMR

EDC

CTMS

eTMF

Job description

Position Title

Senior CRA/Associate Clinical Project Manager

Location

Milpitas, CA (Hybrid model or fully remote work from anywhere in the US for highly qualified candidates)

Job Overview

Associate Clinical Project Manager / Senior CRA collaborates with the core team, 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.

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.

Salary

$92,700.00 - $152,900.00 USD Annual

EEO Statement

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.