Clinical Trial Manager

Scorpion Therapeutics; Malvern (Chester County); On-site; USD 130,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in Malvern, PA, seeks an experienced Clinical Trial Manager to lead planning, execution, and delivery of Phase 1–3 studies while ensuring GCP/ICH compliance and effective vendor management.

You will own the study operational plan, manage timelines and budgets, and coordinate cross-functional teams across Clinical, Regulatory, and QA. Ophthalmology/advanced therapy experience is a plus.

Qualifications

• 5+ years clinical research experience in biotech/pharma
• 2+ years as Clinical Trial Manager
• Experience managing global Phase 1–3 trials and vendor oversight
• Ophthalmology and/or advanced therapy experience strongly preferred
• Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations
• Ability to lead cross-functional teams, manage complex studies, and resolve operational challenges
• Proficiency with CTMS, eTMF, EDC (SAS experience a plus)
• Excellent written/verbal communication; detail-oriented and organized

Responsibilities

• Lead planning, execution, and delivery of clinical studies per GCP/ICH and regs
• Own the study operational plan and align with protocol and program goals
• Manage timelines, enrollment projections, budget tracking, and risk mitigation
• Oversee study vendors (CROs, central labs, IRT, eCOA); contracting and performance
• Lead internal and external clinical teams; ensure training, consistency, accountability across sites
• Contribute to development/review of protocols, amendments, CRFs, ICFs, and study reports
• Lead site identification, qualification, initiation, and training; support investigator meetings
• Ensure clinical systems (CTMS, eTMF, EDC) are used effectively and maintained
• Review trial budgets and site expenses; approvals as appropriate
• Collaborate with Finance (forecast/manage budgets) and Quality (audit readiness)
• Support regulatory submissions and external safety board data reviews as applicable
• Identify and implement process improvements to enhance trial execution
• Act as cross-functional liaison between Clinical, Regulatory, QA, Finance, and external partners
• Contribute to clinical publications/scientific communications as needed
• Perform additional projects as assigned

Skills

Clinical trial management

Vendor/CRO oversight

GCP/ICH knowledge

Cross-functional leadership

Communication skills

Regulatory knowledge

SAS

CTMS

Education

Bachelor’s degree in life sciences or related field

Advanced degree a plus

Tools

CTMS

eTMF

EDC

SAS

Job description

Responsibilities:

• Lead planning, execution, and delivery of clinical studies in accordance with GCP/ICH, SOPs, and regulatory requirements.
• Own the study operational plan and ensure alignment with the scientific protocol and program goals.
• Manage clinical timelines, enrollment projections, budget tracking, and risk mitigation.
• Serve as primary point of contact for study vendors (e.g., CROs, central labs, IRT, eCOA); oversee selection, scope, contracting, and performance.
• Oversee internal and external clinical study teams; ensure training, consistency, and accountability across trial sites.
• Contribute to development/review of protocols, amendments, CRFs, ICFs, and study reports (e.g., annual reports, IBs).
• Lead site identification, qualification, initiation, and training; support investigator meetings and site communications.
• Ensure clinical systems (CTMS, eTMF, EDC) are used effectively and maintained accurately.
• Review trial budgets and site expenses; provide approvals as appropriate.
• Collaborate with Finance (forecast/manage budgets) and Quality (audit readiness and audit plans).
• Support regulatory submissions and external safety board data reviews as applicable.Independently manage LDNA assessments at designated sites; oversee LDNA coordinator(s); maintain SOPs/manuals.
• Identify and implement process improvements to enhance clinical trial execution.
• Act as cross-functional liaison between Clinical, Regulatory, QA, Finance, and external partners.
• Contribute to clinical publications/scientific communications as needed.
• Perform additional projects as assigned.

Qualifications:

• Bachelor’s degree in life sciences or related field (advanced degree a plus).
• 5+ years clinical research experience in biotech/pharma; 2+ years as a Clinical Trial Manager.
• Experience managing global Phase 1–3 trials and vendor/CRO oversight.
• Ophthalmology and/or advanced therapy experience strongly preferred.
• Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
• Ability to lead cross-functional teams, manage complex studies, and resolve operational challenges.
• Proficiency with CTMS, eTMF, EDC (SAS experience a plus).
• Excellent written/verbal communication; detail-oriented and organized.
• Self-directed, collaborative, and flexible in a fast-paced environment.