Manager Clinical Affairs

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

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Relocation assistance may be available

About the role:

The Manager Clinical Affairs at Becton, Dickinson and Company will manage work related to clinical operations professionals and clinical affairs while maintaining strong KOL and other stakeholder relationships. Coordinates and oversees all clinical trial startup and site closure activities, ensuring that regulatory, ethical, contractual, and operational requirements are completed efficiently throughout the study lifecycle. Facilitates timely site activation to accelerate study initiation and minimize time to first patient enrolled, while also managing site closeout activities to ensure proper study termination, regulatory compliance, investigational product accountability, essential document reconciliation, and closure of site obligations.

Job Responsibilities:

• 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).

• Prepares, compiles, and manages all end-to-end study documentation, including regulatory submissions, essential study documents, site contracts and budgets, feasibility and readiness assessments, and compliance-related requirements.

• Collaborates with cross-functional teams and investigative sites to ensure timely approvals, site preparedness, and adherence to applicable regulations, sponsor requirements, and study timelines.

• Provide strategic direction on field and remote monitoring as required 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 process improvement.

• Identify and mitigate risks due to multiple competing priorities.

• Collaborate cross-functionally with R&D, Regulatory Affairs, Marketing, and Quality Assurance to integrate clinical perspectives throughout the product lifecycle.

Minimum Education and Experience Required:

• 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 other closely related relevant experience.

• 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

• Experience working across organizational levels and proactively elevate issues to appropriate levels of management in the organization

• Ability to interact with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Excellent problem-solving and critical thinking skills

• Expert understanding of clinical operations procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Irvine Laguna Canyon

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$129,600.00 - $207,400.00 USD Annual