Senior Manager, Clinical Trials

Scorpion Therapeutics; Kentucky; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

401(k) with matching

Tuition reimbursement

Stock purchase plan

Parental leave

Paid holidays

Job summary

Scorpion Therapeutics in Kentucky is seeking an experienced Clinical Project Manager to lead end-to-end planning and execution of complex global clinical research programs. You will manage site relationships, enrollment tracking, TMF activities, and regulatory compliance to ensure on-time, on-budget trials.

You will oversee CROs and vendors, drive risk management, and partner across Clinical, Regulatory, Data Management, and QA to deliver study success. Travel ~25% may be required.

Qualifications

• 8+ years of clinical research execution in the medical device industry.
• End-to-end medical device trial experience (feasibility, startup, enrollment, monitoring, close-out, inspection readiness).
• Understanding of regulatory authority requirements for clinical study report submissions.
• Experience overseeing CROs/vendors/external partners (selection, budget oversight, performance metrics, escalation, invoice review).
• Ability to manage in-house and external CRO site models and clinical sites (startup/activation, enrollment support, performance).
• Strong risk management, issue resolution, CAPA support, audit readiness, and inspection preparedness.
• Excellent organizational, communication, interpersonal, analytical, and cross-functional skills.
• Proficiency with MS Office; experience with EDC systems and CTMS.

Responsibilities

• Own end-to-end planning and execution of a portfolio of complex global clinical research projects.
• Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviation resolution, and regulatory compliance.
• Manage study timelines and metrics; ensure adherence.
• Plan/lead study-specific meetings (study team, investigator).
• Own operational components such as CRF design and TMF management.
• Partner cross-functionally to ensure alignment and study success.
• Oversee third-party vendors: review reports/budgets/metrics; review and approve vendor invoices.
• Participate in vendor selection/qualification and ongoing oversight.
• Oversee CRO/external vendor performance for site management; review monitoring reports, track KPIs, and elevate performance gaps.
• Ensure trials are executed in compliance with international GCP guidelines/SOPs and applicable mandates.
• Review monitoring visit reports; assist with site monitoring as appropriate.
• Coordinate support for regulatory/ethics committee activities.
• Serve as primary site contact for investigators: provide device protocol training, conduct monitoring, resolve data queries.
• Support QA/audits: resolve findings and CAPAs; ensure audit-ready trial documentation including TMF.
• Maintain integrated study timelines; flag risks/delays to Clinical Development Lead.
• Develop operating budgets; track expenses; negotiate contracts; mitigate financial/operational variances.
• Develop clinical trial documents and support IRB submissions; maintain shared logs.
• Ensure trials complete on schedule and within budget (initiation through close-out).

Education

Bachelor’s degree in life sciences or nursing

Tools

MS Office

EDC systems

CTMS

Job description

Responsibilities

• Own end-to-end planning and execution of a portfolio of complex global clinical research projects.
• Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviation resolution, and regulatory compliance.
• Manage study timelines and metrics; ensure adherence.
• Plan/lead study-specific meetings (study team, investigator).
• Own operational components such as CRF design and TMF management.
• Partner cross-functionally (Clinical, Regulatory, Data Management, Quality, Medical Affairs) to ensure alignment and study success.
• Oversee third-party vendors: review reports/budgets/metrics; review and approve vendor invoices.
• Participate in vendor selection/qualification and ongoing oversight.
• Oversee CRO/external vendor performance for site management; review monitoring reports, track KPIs, and elevate performance gaps.
• Ensure trials are executed in compliance with international GCP guidelines/SOPs and applicable mandates (e.g., FDA, ICH-GCP, ISO 14155).
• Review monitoring visit reports; assist with site monitoring as appropriate.
• Coordinate support for regulatory/ethics committee activities.
• Serve as primary site contact for investigators: provide device protocol training, conduct monitoring, resolve data queries.
• Support QA/audits: resolve findings and CAPAs; ensure audit-ready trial documentation including TMF.
• Maintain integrated study timelines; flag risks/delays to Clinical Development Lead.
• Develop operating budgets; track expenses; negotiate contracts; mitigate financial/operational variances.
• Develop clinical trial documents and support IRB submissions; maintain shared logs (e.g., Study/Site Issue Log, Protocol Deviation Log).
• Ensure trials complete on schedule and within budget (initiation through close-out).

Qualifications

• Bachelor’s degree required (life sciences or nursing preferred).
• 8+ years of clinical research execution in the medical device industry.
• End-to-end medical device trial experience (feasibility, startup, enrollment, monitoring, close-out, inspection readiness).
• Understanding of regulatory authority requirements for clinical study report submissions.
• Experience overseeing CROs/vendors/external partners (selection, budget oversight, performance metrics, escalation, invoice review).
• Ability to manage in-house and external CRO site models and clinical sites (startup/activation, enrollment support, performance).
• Strong risk management, issue resolution, CAPA support, audit readiness, and inspection preparedness.
• Excellent organizational, communication, interpersonal, analytical, and cross-functional skills.
• Proficiency with MS Office; experience with EDC systems and CTMS.
• Minimal travel (~25%).

Preferred Qualifications

• Medical aesthetics energy-based device industry experience.
• KOL networks/investigator community relationships in aesthetics.
• Certifications (CCRP or ACRP-CP).
• Global clinical trial management experience.
• Deep GCP/regulatory knowledge (ISO 14155, ICH, and device regulations).

Benefits (if applicable per posting)

• Medical (includes prescription drug), dental, vision; Flexible Spending Accounts; 401(k) with matching; discretionary time off and paid sick time; stock purchase plan; tuition reimbursement; parental leave; short- and long-term disability; life and AD&D insurance; paid holidays; referral bonuses; employee discounts.