Clinical Trials & Stakeholder Manager

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

Job summary

BD in Irvine, CA is seeking a Manager Clinical Affairs to lead clinical operations, drive startup and site closeout activities, and ensure regulatory and ethical compliance across the study lifecycle. You will collaborate with R&D, Regulatory Affairs, Marketing and Quality Assurance to integrate clinical perspectives, manage documentation, and oversee risk management.

A Bachelor's in Life Sciences and 8+ years of medical device clinical experience are required; BD emphasizes strong on-site

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or related healthcare field.
• 8+ years of medical device clinical experience from study design through execution.
• 5+ years 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.
• Experience interacting across organizational levels and managing cross-functional teams.

Responsibilities

• Oversee start-up activities planning with protocols, informed consents, contracts, scope of work, CRF development.
• Maintain alignment of materials with internal/external stakeholders (R&D, RA, Clinical Affairs, KOLs).
• Prepare, compile, and manage end-to-end study documentation, regulatory submissions, contracts and budgets.
• Collaborate with cross-functional teams and sites for timely approvals and readiness.
• Provide strategic direction on field/remote monitoring and data collection for all clinical trials.
• Act as study project manager, assess data/documents for consistency with protocol and safety.
• Lead identification and implementation of standardized processes across the organization.

Skills

Clinical operations

Sponsor-side operations

Clinical monitoring

Documentation development

Regulatory compliance

KOL management

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Life Sciences, Nursing, or related healthcare field

Advanced degree preferred

Job description

BD in Irvine, CA is seeking a Manager Clinical Affairs to lead clinical operations, drive startup and site closeout activities, and ensure regulatory and ethical compliance across the study lifecycle. You will collaborate with R&D, Regulatory Affairs, Marketing and Quality Assurance to integrate clinical perspectives, manage documentation, and oversee risk management.

A Bachelor's in Life Sciences and 8+ years of medical device clinical experience are required; BD emphasizes strong on-site