Manager Clinical Affairs

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.

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.

Requirements

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

Schedule

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.

Pay

Salary Range: $129,600.00 - $207,400.00 USD Annual.

Benefits

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. 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.