Senior Clinical Trial Manager: Remote & CRO Collaboration

Noveome Biotherapeutics, Inc.; Pittsburgh, Northern (Allegheny County, KY); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Noveome Biotherapeutics, Inc. is seeking a Senior Clinical Trial Manager to oversee the conduct of clinical trials, ensuring adherence to GCP, ICH, CFR, and SOPs.

The role focuses on site engagement, CRO oversight, and timely achievement of study milestones, with emphasis on FDA-regulated processes and robust enrollment strategies. The Senior CTM will manage communications with CROs and trial sites, drive TMF quality, and coordinate start-up activities, newsletters, and site visits.

Qualifications

• FDA regulations and ICH/GCP guidelines knowledge required.
• Experience with regulatory documents and TMF/inspection readiness.
• Clinical trial study start-up, IRB, and trial management experience.
• Strong documentation management and medical terminology knowledge.
• Experience with pediatric regulations, consent/assent processes, and cross-site coordination.
• Analytical thinking and problem-solving across trial activities.

Responsibilities

• Collaborate with CROs, vendors, and clinical research teams to ensure regulatory compliance and timely milestones.
• Monitor trial progress, identify issues, and propose contingency plans for CRO approval.
• Maintain sponsor-site relationships and communicate trial status to management.
• Oversee study timelines, review progress metrics and site-related reports.
• Coordinate TMF setup, maintenance, archiving, and TMF transfer with CROs.
• Support SOP development, standard practices, and quality assessments of TMF documents.
• Coordinate monitoring visits, training, audits, and site engagement as needed.
• Address enrollment barriers and engage transfer sites for early participation opportunities.

Skills

FDA regulations

ICH/GCP familiarity

TMF compliance

Trial management

IRB/start-up experience

Documentation management

Medical terminology

Phase 1-3 trials

Pediatric regulations

Consent/assent dynamics

Analytical thinking

Job description

Noveome Biotherapeutics, Inc. is seeking a Senior Clinical Trial Manager to oversee the conduct of clinical trials, ensuring adherence to GCP, ICH, CFR, and SOPs.

The role focuses on site engagement, CRO oversight, and timely achievement of study milestones, with emphasis on FDA-regulated processes and robust enrollment strategies. The Senior CTM will manage communications with CROs and trial sites, drive TMF quality, and coordinate start-up activities, newsletters, and site visits.