Senior Clinical Regulatory Lead — Sponsor Oversight

Medasource; Philadelphia (Philadelphia County); Hybrid; USD 105,000 - 145,000; Full time

Job summary

Medasource is seeking a Senior Regulatory Specialist – Clinical to support investigator-initiated trials from a sponsor perspective. The role emphasizes sponsor oversight, site/vendor oversight, regulatory compliance, and trial quality in a hybrid PA setting.

The ideal candidate has 5–7 years of related experience, TMF expertise, and the ability to manage multiple studies with strong documentation and communication skills.

Qualifications

• Bachelor’s degree in a life sciences or related field is required.
• 5–7 years of clinical research, clinical operations, or regulatory experience.
• Experience overseeing trials from the sponsor perspective.
• Knowledge of FDA regulations and ICH-GCP.
• Strong written communication and document management skills.

Responsibilities

• Oversee Phase I–IV clinical trials from the sponsor perspective.
• Provide sponsor and site oversight during startup, execution, and closeout.
• Conduct vendor qualifications and ongoing oversight.
• Ensure study activities comply with SOPs, FDA regulations, and ICH-GCP.
• Review core documents: protocols, ICFs, IBs, study manuals, and IRB docs.
• Maintain the TMF and sponsor records.
• Support pharmacovigilance and safety reviews across studies.
• Prepare and support FDA regulatory submissions (amendments, annual and safety reports).
• Work with auditors to ensure inspection readiness.
• Escalate issues to leadership as needed.
• Independently manage multiple studies across priorities.

Skills

Sponsor oversight

Regulatory oversight

Documentation management

Quality oversight

Written communication

Education

Bachelor's degree

ACRP/SOCRA/RAC certifications

Tools

Veeva Vault

eTMF

CTMS platforms

Job description

Medasource is seeking a Senior Regulatory Specialist – Clinical to support investigator-initiated trials from a sponsor perspective. The role emphasizes sponsor oversight, site/vendor oversight, regulatory compliance, and trial quality in a hybrid PA setting.

The ideal candidate has 5–7 years of related experience, TMF expertise, and the ability to manage multiple studies with strong documentation and communication skills.