Clinical Project Manager II / Senior Clinical Project Manager

United Therapeutics Corporation; Chapel Hill (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior or Clinical Project Manager to lead local and regional clinical trials in regenerative medicine and organ transplantation. You will oversee trial lifecycles, work with cross-functional teams, and ensure compliance with GCP/ICH.

Based in Durham, NC with a hybrid schedule and travel up to 30%, the role requires 8–10 years in clinical study management, strong communication, and proficiency with EDC, CTMS, and MS Office.

Qualifications

• Bachelor’s degree with 8+ years (PM II) or 10+ years (Senior) of clinical study management experience in CRO/pharma.
• Strong knowledge of GCP/ICH and experience with EDC/CTMS.
• Excellent communication and ability to work independently and cross-functionally.

Responsibilities

• Oversee entire trial lifecycle, timelines, budgets, quality, and GCP/ICH compliance.
• Coordinate with cross-functional teams, vendors, and investigators.
• Manage study documentation, protocols, and training.
• Monitor KPIs and address issues proactively.
• Contribute to study design, policies, and SOPs.
• Oversee vendor relationships.

Skills

Communication skills

Workload management

Cross-functional collaboration

Education

Bachelor's degree

Master's degree (preferred)

Tools

EDC

CTMS

MS Office

Job description

Role

Senior or Clinical Project Manager leading local/regional clinical trials for biopharma development, with a focus on regenerative medicine and organ transplantation therapies.

Responsibilities

• oversee entire trial lifecycle, ensure adherence to timelines, budgets, quality standards, and compliance with GCP/ICH;
• coordinate with cross-functional teams, vendors, and investigators;
• manage study documentation, protocols, and training;
• monitor KPIs and address issues proactively;
• contribute to study design, policies, and SOPs;
• and oversee vendor relationships.

Requirements

• Bachelor's degree with 8+ years (PM II) or 10+ years (Senior) of clinical study management experience in CRO/pharma;
• strong knowledge of GCP/ICH;
• proficiency with EDC, CTMS, MS Office;
• excellent communication skills;
• ability to handle high workloads and work independently and cross-functionally.

Preferred

• Master’s degree;
• 3+ years in biopharma research roles like CRA or Clinical Manager;
• RN licensure;
• experience across all clinical phases.

High-Value

• experience in regenerative medicine, organ transplant therapies, or rare disease indications;
• working in a regulated clinical environment;
• trial management for biologics or advanced modalities.

Location

Durham, NC with hybrid schedule; travel up to 30%.