Senior Medical Affairs Program Lead - Clinical Trials

BD; Wyckoff (NJ); On-site; USD 172,000 - 275,000; Full time

Benefits offered by this job

Health Savings Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Paid time off

Job summary

BD is a leading global medical technology company based in the United States. We are seeking an experienced Program Manager to lead EP ASCP/ASVP activities, hire and manage staff and vendors, and ensure regulatory compliance across clinical trial sites.

The role emphasizes strong leadership, cross-functional collaboration, and meticulous documentation. The position requires licensed healthcare practitioner credentials, 5+ years in clinical trials and program management, and on-site presence in

Qualifications

• Licensed Healthcare Practitioner (HCP) such as RN, PA, NP.
• Certifications in clinical trial management from recognized training entities (a plus).
• Minimum 5 years’ experience in human clinical trials (GCP experience preferred).
• Minimum 5 years’ experience in Program Management activities and in people management.
• Minimum 3 years’ experience in Site Monitoring (preferred).

Responsibilities

• Provides leadership and assistance to EP ASCP and ASVP staff and allied associates on services, policies, and staff as directed by VP.
• Hires, evaluates and manages EP associates, contractors and/or vendor personnel on program activities.
• Supports global/regional locations or business units expanding program activities.
• Responsible for all submissions and communications with the ASCP IRB and EC.
• Provides monitoring expertise to project teams and manages assigned sites/projects.
• Oversee site staff to ensure protocol adherence and compliance with GCP/ISO and IRB/EC policies.
• Prioritize subject safety and ensure informed consent documentation is complete.
• Maintain audit-ready regulatory files for assigned sites/projects.

Skills

Leadership

Regulatory compliance

Cross-functional collaboration

English fluency

Education

Bachelor's degree in science-related field

Job description

BD is a leading global medical technology company based in the United States. We are seeking an experienced Program Manager to lead EP ASCP/ASVP activities, hire and manage staff and vendors, and ensure regulatory compliance across clinical trial sites.

The role emphasizes strong leadership, cross-functional collaboration, and meticulous documentation. The position requires licensed healthcare practitioner credentials, 5+ years in clinical trials and program management, and on-site presence in