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BD

Manager Clinical Affairs

Location:  Irvine, USA
Location flexibility:  4 office days / week – Based on location and role requirements.
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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 escalate 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.

To learn more about BD visit https://bd.com/careers.

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

.

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

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Working at BD

4 office days / week – Based on location and role requirements.

A little flex time – Based on role requirements.

Company benefits

Health insurance
__ days annual leave + bank holidays
Accrued annual leave
Company shutdown periods
Optional unpaid leave
Reservist leave
Buy or sell annual leave
Compassionate leave
Dental coverage
Fertility benefits
Hertility subscription
Mental health pathway
On-site wellness services
Complimentary Medical Services
Eye Care Support
Fertility treatment leave
Men’s health support
Mental health platform access
Personalised nutrition plan
Wellbeing allowance
Women’s health support
Critical Illness Insurance
Family health insurance
Gym membership
Menopause support
Mental health first aiders
Mental health support
Private GP service
Wellbeing incentive programme
Mentoring
Coaching
Learning platform
Further education support
Study support
Professional subscriptions
Collaboration spaces
Bike parking
On-site wellness room
Secure on-site parking
Cycle to work scheme
On-site barista
Private booths
Sensory-Friendly Setup
Chill out zone
Ergonomic workstations
Meditation space
On-site catering
On-site gym
On-site shower
On-site workout classes
Adoption leave
Eldercare services
Shared parental leave
Pregnancy loss leave
Summer holiday childcare
Carer’s leave
Emergency leave
Pregnancy support
401K
Annual pay rises
Equity packages
Salary advance
Additional voluntary pension contribution
Electric Car Salary Sacrifice
Income protection
Life assurance
Salary sacrifice
Nursery salary sacrifice scheme
Annual bonus
Enhanced pension match/contribution
Life insurance
Referral bonus
Share options
Theme park discounts
Cinema discounts
Coffee discounts
Restaurant discounts
Travel insurance
Employee recognition scheme
Career and family coaching
Death in service
Employee discounts
Sabbaticals
Sports teams
Workplace loan
Charity donation scheme
Company wide holidays/offsites
Financial advice
Relocation packages
Teambuilding days
Volunteer days
Car allowance
Company car
Employee assistance programme
Financial coaching
In house training
Neonatal leave
Physiotherapy
Will writing
Modern office
Enhanced maternity leave
Enhanced paternity leave
Tax-free childcare
Women’s health leave
Enhanced maternity leave
Women’s health leave
Non-contributory pension
Religious celebration leave
Bank holiday swaps
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Company employees:

60,000+

Office Locations