BD · 1 month ago
Senior Manager, Clinical Affairs APM
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$158K/yr - $261K/yr
8+ years expBD is one of the largest global medical technology companies in the world, seeking a Senior Manager, Clinical Affairs to lead strategic initiatives within their Advanced Patient Monitoring portfolio. This role involves overseeing a clinical operations team, managing clinical trials, and shaping clinical strategies to improve patient outcomes through innovative technology.
Health CareMedical DeviceTechnical Support
Responsibilities
Manage and oversee the work of a clinical operations team and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department. Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs
Oversee the planning of start-up activities (e.g., protocols, informed consents, contracts, scope of work, case report form development, training materials) with accountability for successful completion within scope of project deliverables. Maintain high level continuity of materials developed and ensure alignment with internal and external stakeholder needs (e.g., R&D, RA, Clinical Affairs, KOLs)
Provide strategic direction on field and remote monitoring of studies and data collection for all clinical trials, act as a study project manager, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
Lead in the identification and evaluation of alignment opportunities to standardized processes across the organization and lead the implementation of course correction
Identify and mitigate risks due to multiple competing timeline assessments
Qualification
Required
Bachelor's degree in related sciences field
8 years progressive experience in medical device clinical trial design, planning and execution
5 years experience with hands-on clinical research monitoring
3 years of proven experience in direct people management, including coaching, mentoring, and developing high-performing teams to achieve organizational goals
Proven strategic planning skills for IDE, NSR IDE, post-market medical device studies
Proven successful project management skills with meticulous attention to detail
Proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills (Pivot Tables, VLOOKUP)
Exceptional written and verbal communication skills, with strong interpersonal abilities including negotiation and relationship management to drive objectives
Expert-level knowledge of clinical operations procedures, with the ability to resolve complex, cross-functional issues and influence outcomes beyond the immediate team
Extensive knowledge of human anatomy and physiology
Exceptional problem-solving, organizational, analytical, and critical thinking abilities, with a proven track record of delivering innovative solutions
Strong leadership skills with the ability to inspire teams and drive meaningful change across the organization
Ability to build strong relationships and communicate effectively across all organizational levels, proactively escalating issues to ensure timely resolution and alignment with strategic objectives
Proven expertise in fostering collaboration with customers and cross-functional teams, frequently leading and influencing joint initiatives to achieve project success
Ability to travel up to 20%
Preferred
Experience with preparation of clinical trial documentation and study reports preferred
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
Company data provided by crunchbase