Senior Clinical Trial Manager
Kymera Therapeutics
1 month ago
Remote friendly (Greater Boston)
United States
Clinical Research and Development
How you’ll make an impact:
- Drive end-to-end trial execution (operational quality, budget/timeline adherence, activation and recruitment goals); proactively identify and mitigate risks to study delivery.
- Lead planning and execution of study-specific meetings (internal team meetings, investigator meetings, risk reviews, lessons learned) to ensure alignment and progress across stakeholders.
- Oversee CRO/vendor performance (eCOA, IRT, central labs): set expectations, manage deliverables, and serve as primary point of contact/subject matter expert; contribute to vendor selection, specifications, UAT, and ongoing oversight.
- Lead or contribute to development/review of key study documents (Clinical Study Protocol, informed consent forms, Clinical Trial Oversight Plan, Pharmacy Manual, and applicable study plans across Kymera and CRO).
- Provide oversight of data quality and integrity (eCRF input, edit checks, data review plans; monitor data entry/query resolution; drive data cleaning with Data Management, Medical, and Safety to support analyses and database locks).
- Ensure clinical/monitoring oversight via review of monitoring outputs (reports, central monitoring, protocol deviations, medical data), identify trends, escalate issues, implement corrective actions; perform Clinical Monitoring Oversight Visits when required.
- Ensure inspection readiness and compliance (Clinical Trial Oversight Plan, ICH/GCP, regulatory requirements), including eTMF quality/completeness and support of CTA activities.
- Build/maintain relationships with investigators and site staff; represent Kymera at key study events (e.g., SIVs).
- Contribute to continuous process improvement (study and department level).
- Travel up to 25% (may be required).
Skills and experience you’ll bring:
- 8+ years in clinical research (CRO/biotech/pharma), including 3+ years as a sponsor Clinical Trial Manager.
- Experience leading Phase 2 and/or Phase 3 trials from RFP to CSR.
- Respiratory or Immunology experience highly preferred.
- Strong knowledge of regulatory/ICH-GCP requirements and guidelines: CFR, HIPAA, Protection of Human Research Subjects, GDPR.
- Strong project management (manage multiple trials simultaneously).
- Excellent problem-solving, leadership, and communication skills.
- Ability to work in a fast-paced, dynamic environment with cross-functional teams.
Compensation:
- Anticipated base salary range: $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- Drive end-to-end trial execution (operational quality, budget/timeline adherence, activation and recruitment goals); proactively identify and mitigate risks to study delivery.
- Lead planning and execution of study-specific meetings (internal team meetings, investigator meetings, risk reviews, lessons learned) to ensure alignment and progress across stakeholders.
- Oversee CRO/vendor performance (eCOA, IRT, central labs): set expectations, manage deliverables, and serve as primary point of contact/subject matter expert; contribute to vendor selection, specifications, UAT, and ongoing oversight.
- Lead or contribute to development/review of key study documents (Clinical Study Protocol, informed consent forms, Clinical Trial Oversight Plan, Pharmacy Manual, and applicable study plans across Kymera and CRO).
- Provide oversight of data quality and integrity (eCRF input, edit checks, data review plans; monitor data entry/query resolution; drive data cleaning with Data Management, Medical, and Safety to support analyses and database locks).
- Ensure clinical/monitoring oversight via review of monitoring outputs (reports, central monitoring, protocol deviations, medical data), identify trends, escalate issues, implement corrective actions; perform Clinical Monitoring Oversight Visits when required.
- Ensure inspection readiness and compliance (Clinical Trial Oversight Plan, ICH/GCP, regulatory requirements), including eTMF quality/completeness and support of CTA activities.
- Build/maintain relationships with investigators and site staff; represent Kymera at key study events (e.g., SIVs).
- Contribute to continuous process improvement (study and department level).
- Travel up to 25% (may be required).
Skills and experience you’ll bring:
- 8+ years in clinical research (CRO/biotech/pharma), including 3+ years as a sponsor Clinical Trial Manager.
- Experience leading Phase 2 and/or Phase 3 trials from RFP to CSR.
- Respiratory or Immunology experience highly preferred.
- Strong knowledge of regulatory/ICH-GCP requirements and guidelines: CFR, HIPAA, Protection of Human Research Subjects, GDPR.
- Strong project management (manage multiple trials simultaneously).
- Excellent problem-solving, leadership, and communication skills.
- Ability to work in a fast-paced, dynamic environment with cross-functional teams.
Compensation:
- Anticipated base salary range: $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.