Senior Clinical Trial Manager

Scorpion Therapeutics; Boston (MA); On-site; USD 176,000 - 197,000; Full time

Benefits offered by this job

Compensation range: $176K–$197K

Job summary

Scorpion Therapeutics in Boston is seeking an experienced Clinical Operations leader to execute high-touch, adaptive trial strategies that support registration. You will oversee timelines, budgets, procedures, and quality, coordinating with CROs and partners to ensure delivery.

The role requires 5+ years in clinical trial management, global oversight, and strong leadership. Oncology experience and CRO/vendor oversight skills are strongly preferred; travel 10–20% is expected.

Qualifications

• Bachelor’s degree required (Life Sciences preferred).
• 5+ years clinical trial management experience in pharma/biotech/CRO.
• Ability to manage global clinical trials across regions.
• Phase 2/Phase 3 experience strongly preferred.
• Oncology study experience strongly preferred.
• Clinical research operations knowledge; project planning with CRO/vendor oversight.
• Global clinical trial management in fast-paced CRO outsourced environment.
• Experience managing global/regional teams in a virtual environment.
• Strong decision-making and communication; analytic problem-solving.
• Adaptable; thrives in fast-paced environment.
• Travel 10–20% of the time.

Responsibilities

• Execute clinical operations strategy for high-touch, patient-centered trials, with adaptive and seamless designs to support registration.
• Ensure trial deliverables are met on timelines, budget, operational procedures, and quality standards.
• Manage relationships and work efficiently with external collaboration partners.
• Proactively identify, assess, and manage clinical study challenges and risks.
• Support oversight of study activities including site identification/selection, enrollment models, clinical supply planning, budget planning, and trial execution.
• Monitor CRO/third-party vendor performance and compliance with applicable regulations/guidelines through regular contact (e.g., CRAs).
• Develop and/or revise CRO scope of service agreements, budgets, plans, and detailed timelines to ensure performance expectations are met.
• Participate in development/authorship of study documents (e.g., protocol, investigator brochure, informed consent).
• Participate in Case Report Form design, user acceptance testing with Data Management, and data monitoring.
• Oversee study management and/or clinical development teams (CROs) to meet clinical development goals and study quality metrics.
• Execute CRO/third-party oversight (e.g., monitoring report review, periodic data quality review, CRO/vendor KPI review, sponsor oversight visits).
• Contribute to and/or author clinical sections of regulatory documents (e.g., Investigator’s Brochures, safety updates, responses to Health Authority/Ethics Committee questions).
• May manage a team of Clinical Trial Associates (hiring, career/professional development).

Skills

Clinical trial management

Global trial management

CRO/vendor oversight

Protocol development

Cross-functional leadership

Budget & timeline planning

Regulatory compliance

Team leadership

Travel willingness

Risk management

Education

Bachelor’s degree

Job description

Responsibilities:

• Execute clinical operations strategy for high-touch, patient-centered clinical trials, with a focus on adaptive and seamless designs to support registration.


• Ensure trial deliverables are met on timelines, budget, operational procedures, and quality standards (may include contributing to study documents, developing study tools/guidelines/training, managing clinical study materials, and implementing issue resolution plans).


• Manage relationships and work efficiently with external collaboration partners.


• Proactively identify, assess, and manage clinical study challenges and risks.


• Support oversight of study activities including site identification/selection, enrollment models, clinical supply planning, budget planning, and trial execution.


• Monitor CRO/third-party vendor performance and compliance with applicable regulations/guidelines through regular contact (e.g., CRAs).


• Develop and/or revise CRO scope of service agreements, budgets, plans, and detailed timelines to ensure performance expectations are met.


• Participate in development/authorship of study documents (e.g., protocol, investigator brochure, informed consent).


• Participate in Case Report Form design, user acceptance testing with Data Management, and data monitoring.


• Oversee study management and/or clinical development teams (CROs) to meet clinical development goals and study quality metrics.


• Execute CRO/third-party oversight (e.g., monitoring report review, periodic data quality review, CRO/vendor KPI review, sponsor oversight visits).


• Contribute to and/or author clinical sections of regulatory documents (e.g., Investigator’s Brochures, safety updates, responses to Health Authority/Ethics Committee questions).


• May manage a team of Clinical Trial Associates (hiring, career/professional development).

Qualifications:

• Bachelor’s degree required (preferably Life Sciences: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).


• 5+ years clinical trial management experience in pharma/biotech/CRO.


• Ability to manage global clinical trials across regions (regulatory, cultural, and site capability differences).


• Phase 2/Phase 3 experience strongly preferred.


• Oncology study experience strongly preferred.


• Clinical research operational knowledge; computer literacy; strong project planning/management with CRO/vendor oversight.


• Global clinical trial management in fast-paced CRO outsourced environment.


• Experience managing global/regional teams in a virtual environment.


• Strong decision-making and communication/collaboration; analytic problem-solving.


• Adaptable; thrives in fast-paced environment.


• Effective leadership; ability to foster productivity, cohesiveness, and quality deliverables.


• Travel 10–20% of the time.

Benefits/compensation:

• Compensation range: $176K–$197K.