Senior Manager, Clinical Trials

Scorpion Therapeutics; Bothell (WA); On-site; USD 140,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

401(k) match

Stock purchase plan

Tuition reimbursement

Parental leave

Discretionary time off

Job summary

Scorpion Therapeutics seeks a senior Clinical Operations Lead in Bothell, WA to own global device trials from feasibility to inspection readiness. You will drive cross-functional study planning, vendor oversight, and regulatory submissions, ensuring GCP, ISO 14155 and FDA expectations are met.

Travel up to 25% and lead risk management activities with CROs and internal teams. The role emphasizes collaboration with Regulatory, Data Management, QA and Medical Affairs to keep timelines and budgets

Qualifications

• Bachelor's degree in life sciences or nursing preferred.
• 8+ years clinical research execution in medical devices.
• End-to-end medical device clinical trial experience (feasibility through inspection readiness).
• Regulatory knowledge for clinical study report submissions.
• Proven CRO/vendor oversight (selection, budgets, KPIs, escalation, invoice review).
• Strong risk management, issue resolution, CAPA support, audit readiness/inspection preparedness.
• Excellent organizational, communication, analytical, and cross-functional skills; MS Office; EDC and CTMS experience.
• Minimal travel (~25%).

Responsibilities

• Own end-to-end planning and execution of a global portfolio of complex clinical research projects.
• Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviations, and regulatory compliance.
• Maintain study timelines/metrics; lead study-specific meetings.
• Own operational components including CRF design and TMF management.
• Partner cross-functionally (Clinical, Regulatory, Data Management, Quality, Medical Affairs) to ensure study success.
• Oversee third-party vendors: review budgets/metrics/reports and approve invoices; participate in vendor selection/qualification/oversight.
• Oversee CRO/vendor performance for site management; review monitoring reports, track KPIs, and elevate gaps.
• Ensure trials are executed in compliance with GCP/SOPs and applicable mandates (FDA regulations, ICG-GCP, ISO 14155).
• Review monitoring visit reports; provide investigator training, conduct monitoring visits, resolve data queries.
• Support regulatory/ethics committee activities; support QA/audits, CAPAs, and audit-ready TMF.
• Maintain shared documents/logs; support IRB submissions; keep studies on schedule and within budget.

Skills

Clinical operations

Study planning

Vendor oversight

Regulatory knowledge

GCP compliance

Data management

Communication

Project management

Travel readiness

Education

Bachelor's degree in life sciences or nursing

Tools

MS Office

EDC

CTMS

Job description

Responsibilities:

• Own end-to-end planning and execution of a global portfolio of complex clinical research projects.
• Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviations, and regulatory compliance.
• Maintain study timelines/metrics; lead study-specific meetings.
• Own operational components including CRF design and TMF management.
• Partner cross-functionally (Clinical, Regulatory, Data Management, Quality, Medical Affairs) to ensure study success.
• Oversee third-party vendors: review budgets/metrics/reports and approve invoices; participate in vendor selection/qualification/oversight.
• Oversee CRO/vendor performance for site management; review monitoring reports, track KPIs, and elevate gaps.
• Ensure trials are executed in compliance with GCP/SOPs and applicable mandates (e.g., FDA regulations, ICG-GCP, ISO 14155).
• Review monitoring visit reports; provide investigator training, conduct monitoring visits, resolve data queries.
• Support regulatory/ethics committee activities; support QA/audits, CAPAs, and audit-ready TMF.
• Maintain shared documents/logs (e.g., issue and protocol deviation logs); support IRB submissions; keep studies on schedule and within budget.

Qualifications & Required Skills:

• Bachelor's degree (life sciences or nursing preferred).
• 8+ years clinical research execution in medical devices.
• End-to-end medical device clinical trial experience (feasibility through inspection readiness).
• Regulatory knowledge for clinical study report submissions.
• Proven CRO/vendor oversight (selection, budgets, KPIs, escalation, invoice review) and management of in-house vs. external site models.
• Strong risk management, issue resolution, CAPA support, audit readiness/inspection preparedness.
• Excellent organizational, communication, analytical, and cross-functional skills; MS Office; EDC and CTMS experience.
• Minimal travel (~25%).

Preferred Qualifications:

• Medical aesthetics energy-based device experience; KOL/investigator relationships in aesthetics.
• CCRP or ACRP-CP certification.
• Global clinical trial management experience; deep GCP/regulatory knowledge (ISO 14155, ICH).

Benefits (as listed):

• Medical (includes prescription drug), dental, vision; FSA; 401(k) match; discretionary time off; paid sick time; stock purchase plan; tuition reimbursement; parental leave; short- and long-term disability; life and accidental death & dismemberment insurance; paid holidays; referral bonuses; employee discounts.