Clinical Operations Leader - MedTech Trials

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

Benefits offered by this job

Relocation assistance

Job summary

BD is seeking a Manager of Clinical Affairs in the Irvine area to oversee clinical operations, regulatory submissions, and site management throughout the study lifecycle. This role emphasizes rapid site activation, KOL engagement, and cross-functional collaboration with R&D, Regulatory Affairs, Marketing, and Quality Assurance.

The incumbent will lead end-to-end documentation, manage budgets and contracts, and drive standardized processes while ensuring GCP compliance and patient safety

Qualifications

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

Responsibilities

• Oversee startup activities (protocols, consents, contracts, training materials) within scope.
• Maintain alignment with R&D, RA, Clinical Affairs, and KOLs.
• Prepare and manage end-to-end study documentation and regulatory submissions.
• Collaborate with cross-functional teams to ensure timely approvals and site readiness.
• Provide strategic direction on field/remote monitoring and data collection.
• Lead process improvements and mitigate risks across projects.

Skills

Clinical operations

KOL management

Regulatory requirements

GCP compliance

Stakeholder management

Contract & budgeting

Education

Bachelor's degree Life Sciences

Nursing

Advanced degree preferred

Job description

BD is seeking a Manager of Clinical Affairs in the Irvine area to oversee clinical operations, regulatory submissions, and site management throughout the study lifecycle. This role emphasizes rapid site activation, KOL engagement, and cross-functional collaboration with R&D, Regulatory Affairs, Marketing, and Quality Assurance.

The incumbent will lead end-to-end documentation, manage budgets and contracts, and drive standardized processes while ensuring GCP compliance and patient safety