Senior Clinical Trial Manager

Scorpion Therapeutics; Malvern (Chester County); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a seasoned clinical operations professional to independently lead planning, execution, and delivery of clinical studies in line with GCP/ICH, SOPs, and regulatory requirements. You will drive study timelines, enrollment milestones, and vendor coordination while maintaining visibility into critical paths and risks.

The role requires strong study start-up experience, site activation, and collaboration with cross-functional teams.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree a plus.
• 7–10 years clinical research experience in biotech/pharma, incl. clinical trials.
• Experience managing timelines, vendors, and operational risks.
• Strong knowledge of ICH-GCP, FDA, and international regulations.
• Experience with CTMS, EDC, and eTMF; Veeva eTMF or comparable systems.
• Experience supporting study start-up and site activation.
• Ability to operate independently, prioritize, and drive execution in a fast-paced environment.
• Strong organizational, communication, and problem-solving skills.

Responsibilities

• Independently lead planning, execution, and delivery of clinical studies per GCP/ICH, SOPs, and regulatory requirements.
• Drive study timelines, enrollment execution, and milestones; maintain visibility into critical paths, dependencies, and timelines.
• Anticipate operational risks and implement mitigation strategies to prevent delays or quality issues.
• Lead or significantly contribute to study start-up and site activation (site feasibility, vendor coordination, regulatory package readiness, site timelines).
• Support investigator selection, site qualification, and initiation activities.
• Build and maintain relationships with investigators and study physicians; support enrollment strategy and site performance.
• Serve as primary operational contact for CROs and vendors; ensure performance, timelines, and quality; lead vendor governance and issue resolution.
• Oversee eTMF completeness, quality, and inspection readiness; ensure timely filing and quality control in Veeva eTMF and other clinical systems; support audit/inspection readiness.
• Collaborate with Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance; resolve operational challenges.
• Serve in an unblinded operational role when required, maintaining confidentiality and protocol compliance.
• Forecast and monitor study budgets with Finance and Clinical leadership; identify and address risks to timelines, resources, or costs.
• Travel to investigator sites, meetings, and vendors as required.
• Identify and implement process improvements to enhance execution and efficiency.

Skills

Communication

Organizational skills

Problem-solving

Independent work

Prioritization

Education

Bachelor’s degree in life sciences or related field

Advanced degree a plus

Tools

CTMS

EDC

eTMF

Veeva eTMF

Job description

Responsibilities:

• Independently lead planning, execution, and delivery of clinical studies per GCP/ICH, SOPs, and regulatory requirements.
• Drive study timelines, enrollment execution, and operational milestones; maintain visibility into critical paths, dependencies, and timelines.
• Anticipate operational risks and implement mitigation strategies to prevent delays or quality issues.
• Lead or significantly contribute to study start-up and site activation (site feasibility, vendor coordination, regulatory package readiness, site timelines).
• Support investigator selection, site qualification, and initiation activities.
• Build and maintain relationships with investigators and study physicians; support enrollment strategy and site performance.
• Serve as primary operational contact for CROs and vendors; ensure performance, timelines, and quality; lead vendor governance and issue resolution.
• Oversee eTMF completeness, quality, and inspection readiness; ensure timely filing and quality control in Veeva eTMF and other clinical systems; support audit/inspection readiness.
• Collaborate with Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance; resolve operational challenges.
• Serve in an unblinded operational role when required, maintaining confidentiality and protocol compliance.
• Forecast and monitor study budgets with Finance and Clinical leadership; identify and address risks to timelines, resources, or costs.
• Travel to investigator sites, meetings, and vendors as required.
• Identify and implement process improvements to enhance execution and efficiency.

Qualifications:

• Bachelor’s degree in life sciences or related field (advanced degree a plus).
• 7–10 years clinical research experience in biotech/pharma, including managing clinical trials.
• Demonstrated experience managing timelines, vendors, and operational risks.
• Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
• Experience with CTMS, EDC, and eTMF; Veeva eTMF or comparable systems.
• Experience supporting study start-up and site activation.
• Ability to operate independently, prioritize, and drive execution in a fast‑paced, changing environment.
• Strong organizational, communication, and problem‑solving skills.

Preferred:

• Experience in ophthalmology, advanced therapies, or small to mid-size biotech.
• Experience in an unblinded study environment.
• Experience engaging investigators and study physicians directly.

Working Conditions:

• Office setting when not traveling; domestic and international travel may be required.