Clinical Operations Senior Manager

Scorpion Therapeutics; Lexington (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced Clinical Trial Operations Leader to drive trials from startup to database lock. You will manage cross-functional teams and CROs, oversee site start-up, IRB submissions, and monitoring, and ensure protocol adherence to GCP and regulatory standards.

The role requires global trial leadership for Phase 1–3, budget management, and strong communication. You will develop study materials, support eClinical systems, and maintain quality across data and

Qualifications

• 7+ years in clinical operations (sponsor or CRO).
• Global experience; cardiovascular, rare disease, and/or Phase 1 experience preferred.
• Experience managing domestic/international Phase 1-3 trials and site start-up.
• Strong project and risk management.
• Excellent written/spoken communication and interpersonal skills.
• Site monitoring and clinical quality compliance experience preferred.
• Advanced GCP knowledge and FDA IND regulations knowledge.
• Extensive CRO/vendor selection and management experience.
• Experience delivering clinical study reports and regulatory sections (IND/CTA/BLA/MAA/NDA; eCTD Module 1 data).
• Ability to forecast/manage budgets across studies.
• Proficiency with electronic clinical database software and Microsoft Office.

Responsibilities

• Independently manage clinical trial operations from start-up through database lock.
• Lead internal cross-functional study teams and partner with CROs for timely execution.
• Participate in protocol design, site selection, and IRB/EC submissions.
• Manage vendors/CROs and serve as primary contact; identify risks and resolve issues.
• Perform/oversee site monitoring visits as needed.
• Support protocol amendments and development of eClinical systems (EDC, IRT).
• Develop/coordinate study materials (Monitoring/Data Management Plans, eCRF, guidelines).
• Review monitoring reports and data listings for quality.
• Coordinate CROs for site selection, IRB submissions, initiation and close-out.
• Create/manage reports on study progress and key metrics for senior management.
• Coordinate site budget negotiations and oversee site payments.
• Facilitate study drug ordering and drug chain record/accountability; manage non-drug supply ordering.
• Oversee maintenance of clinical trial master files for regulatory/ICH-GCP compliance.
• Provide input to IND filings, CTAs, safety reports, and clinical study reports.
• Ensure adverse events and product safety issues are captured timely.
• Forecast/reforecast investigational product needs and communicate routinely.
• Support inspection readiness and audits with CROs/sites; respond to findings.

Skills

Project management

Clinical operations

Cross-functional collaboration

GCP knowledge

Budget management

Communication skills

Vendor management

Risk management

Education

Bachelor's or higher in health/biologic sciences

Master's degree preferred

Tools

EDC systems

MS Office

Job description

Responsibilities:

• Independently manage clinical trial operational activities from start-up through database lock, accelerating project launch and site start-up/activations while ensuring protocol, GCP, and SOP adherence.
• Lead internal cross-functional study teams and partner with CROs for effective, timely communication and execution within timeline and budget.
• Participate in protocol design, CRO and site selection, and IRB/EC submissions for early and late-phase studies.
• Manage vendors/CROs and serve as primary point of contact; identify risks, resolve issues, manage vendor plans, and review quality metrics.
• Perform/oversee site monitoring visits as needed.
• Support protocol amendments and development/revision of eClinical systems (e.g., EDC, IRT).
• Develop/coordinate study materials (Clinical Monitoring/Data Management Plans, eCRF and guidelines, protocols, consent drafts, specimen instructions, drug order forms).
• Review monitoring reports, protocol deviations, and data listings for quality.
• Coordinate CROs for site selection, IRB submissions, initiation, and close-out.
• Create/manage reports on study progress and key metrics for Senior Management and program teams.
• Coordinate site budget negotiations and oversee site payments.
• Facilitate study drug ordering and drug chain record/accountability; manage non-drug supply ordering/tracking as required.
• Oversee maintenance of clinical trial master files for regulatory/ICH-GCP compliance.
• Provide input to IND filings, CTAs, safety reports, clinical study reports, and ICH-compliant dossier sections (BLA/MAA/NDA, etc.).
• Ensure adverse events/product safety issues are captured and evaluated timely.
• Forecast/reforecast investigational product needs and communicate routinely.
• Support inspection readiness and audits/inspections with CROs and sites; respond to findings.

Qualifications:

• BS/BA/BScN or higher in health/biologic sciences (Master's preferred).
• 7+ years clinical operations experience (sponsor or CRO), including 3 years as clinical study lead/project manager.
• Global experience required; cardiovascular, rare disease, and/or Phase 1 experience preferred.
• Experience managing domestic/international Phase 1-3 trials and investigational site start-up.
• Strong project and risk management.
• Excellent written/spoken communication and interpersonal skills.
• Site monitoring and clinical quality compliance experience strongly preferred.
• Advanced GCP knowledge and working knowledge of FDA IND regulations and other country requirements.
• Extensive CRO/vendor selection and management experience.
• Experience delivering clinical study reports and preparing regulatory clinical sections (IND/CTA/BLA/MAA/NDA; eCTD Module 1 data).
• Ability to forecast/manage budgets across studies.
• Proficiency with electronic clinical database software and Microsoft Office.

Required onsite:

• Lexington, MA office; onsite five days/week.