Clinical Operations Manager, Trials & Compliance

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

Job summary

BD Irvine is seeking a Manager Clinical Affairs to oversee clinical operations, startup activities, and site closeouts, ensuring compliance with regulatory and ethical requirements across the study lifecycle. You will lead cross-functional teams, develop study documents, coordinate with R&D, RA, and KOLs, and drive process improvements while maintaining strong relationships with investigators and sponsors.

Relocation assistance may be available; on-site collaboration is emphasized to support

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.
• 5+ years sponsor-side clinical operations experience.
• 5+ years clinical monitoring experience.
• Proven experience developing clinical study documents, protocols, and study reports.
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Experience working across organizational levels and elevating issues to appropriate levels of management
• Ability to interact with customers and cross-functional peers; leads project teams
• Excellent written and verbal communication; interpersonal skills including negotiation
• Expert understanding of clinical operations procedures

Responsibilities

• Oversee the planning of start-up activities with accountability for deliverables.
• Maintain high-level continuity of materials and alignment with stakeholder needs.
• Prepares, compiles, and manages all end-to-end study documentation and regulatory submissions.
• Collaborates with cross-functional teams and investigative sites for timely approvals and readiness.
• Provide strategic direction on field and remote monitoring and data collection for trials.
• Act as a study project manager and monitor documentation against study protocol.
• Lead in alignment opportunities to standardized processes and implement improvements.
• Identify and mitigate risks due to multiple competing priorities.
• Collaborate cross-functionally to integrate clinical perspectives throughout the product lifecycle.

Skills

Problem solving

Organizational skills

Analytical thinking

Communication skills

Interpersonal skills

Leadership

Risk management

Cross-functional teamwork

Decision making

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

BD Irvine is seeking a Manager Clinical Affairs to oversee clinical operations, startup activities, and site closeouts, ensuring compliance with regulatory and ethical requirements across the study lifecycle. You will lead cross-functional teams, develop study documents, coordinate with R&D, RA, and KOLs, and drive process improvements while maintaining strong relationships with investigators and sponsors.

Relocation assistance may be available; on-site collaboration is emphasized to support