Senior Clinical Affairs Manager – Trials & Operations

Becton Dickinson NA; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

Becton, Dickinson and Company (BD) is seeking a Manager of Clinical Affairs to lead clinical operations, coordinate site startup and closeout, and ensure regulatory compliance across studies at the Irvine, CA site. You will manage cross-functional teams and oversee documentation, site contracts, and budgets to accelerate trial initiation and ensure safety and quality in line with GCP.

Ideal candidates possess 8+ years in medical device clinical settings, strong communication skills, and a proven

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.
• 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 (protocols, informed consents, budgets, contracts) to meet project deliverables.
• Maintain alignment of materials with internal and external stakeholders (R&D, RA, Clinical Affairs, KOLs).
• Prepare and manage end-to-end study documentation, regulatory submissions, site contracts and budgets, feasibility and readiness assessments.
• Collaborate with cross-functional teams and sites to ensure timely approvals and adherence to regulations and timelines.
• Provide strategic direction on field and remote monitoring and data collection for all trials; act as study PM and ensure data parameters align with protocol and GCP.

Skills

Clinical operations

KOL management

Regulatory compliance

Project management

GCP knowledge

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Job description

Becton, Dickinson and Company (BD) is seeking a Manager of Clinical Affairs to lead clinical operations, coordinate site startup and closeout, and ensure regulatory compliance across studies at the Irvine, CA site. You will manage cross-functional teams and oversee documentation, site contracts, and budgets to accelerate trial initiation and ensure safety and quality in line with GCP.

Ideal candidates possess 8+ years in medical device clinical settings, strong communication skills, and a proven