Senior Clinical Affairs Manager – Trials & Compliance

BD; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD is seeking a Manager of Clinical Affairs to lead clinical operations and manage relationships with investigators and stakeholders. The role focuses on startup and site closure activities, ensuring regulatory, ethical, contractual, and operational requirements are met across the study lifecycle.

You will coordinate cross-functional teams, manage essential documents, and drive timely site activation while ensuring patient safety and data integrity in line with GCP and regulatory standards.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or related healthcare field; advanced degree preferred.
• 8+ years of medical device clinical experience from study design through execution or related experience.
• 5+ years of sponsor-side clinical operations experience.
• 5+ years of clinical monitoring experience.
• Proven experience developing clinical study documents, protocols, and study reports.
• Excellent problem-solving, organizational, analytical and critical thinking skills.

Responsibilities

• Oversee start-up planning for protocols, informed consents, contracts, training materials, and related deliverables.
• Maintain alignment with R&D, RA, Clinical Affairs, and KOLs across stakeholders.
• Prepare and manage regulatory submissions, essential documents, site contracts, budgets, and readiness assessments.
• Collaborate with cross-functional teams and investigative sites for timely approvals and site readiness.
• Provide strategic direction on field and remote monitoring, act as study project manager, and ensure data documentation aligns with protocol and GCP.
• Lead identification and implementation of standardized processes across the organization.
• Identify and mitigate risks due to competing priorities.
• Collaborate with R&D, Regulatory Affairs, Marketing, and Quality Assurance to integrate clinical perspectives throughout the lifecycle.

Skills

Problem-solving

Organizational skills

Analytical thinking

Communication skills

Cross-functional collaboration

Leadership

Education

Bachelor's degree in Life Sciences/Nursing/Healthcare

Advanced degree preferred

Job description

BD is seeking a Manager of Clinical Affairs to lead clinical operations and manage relationships with investigators and stakeholders. The role focuses on startup and site closure activities, ensuring regulatory, ethical, contractual, and operational requirements are met across the study lifecycle.

You will coordinate cross-functional teams, manage essential documents, and drive timely site activation while ensuring patient safety and data integrity in line with GCP and regulatory standards.