Senior Clinical Trial Lead - Hybrid

Kailera; United States; Hybride; USD 143 000 - 175 000; Plein temps

Avantages offerts par ce poste

Health coverage

401(k) match

Equity grants

Tuition reimbursement

Commuter benefits

Wellness stipend

Résumé du poste

Kailera is seeking a Senior Clinical Trial Manager to oversee one or more trials across all phases. Based in Waltham, MA or remote with a hub visit cadence, this role leads cross-functional teams and manages CROs to ensure trials stay on time and within budget.

The successful candidate will drive trial start-up, monitoring, data review and database lock, maintain Trial Master Files, and mentor junior staff while ensuring GCP/ICH compliance and quality.

Qualifications

• 8+ years in clinical trials with CRO/vendor management.
• Strong knowledge of GCP/ICH and regulatory frameworks.
• Excellent communication and stakeholder management.
• Ability to travel as needed.

Responsabilités

• Lead end-to-end trial execution and oversee CROs from start-up to close-out.
• Guide cross-functional teams on timelines, deliverables, risk mitigation, and study objectives.
• Manage protocol development, site selection, monitoring, data review, and database lock.
• Ensure documentation quality and regulatory compliance.
• Mentor junior staff and drive process improvements.
• Collaborate with QA, Regulatory, and other stakeholders for compliance.

Connaissances

Cross-functional lead

GCP/ICH knowledge

Communication skills

Travel readiness

Vendor management

Formation

Bachelor’s degree in life sciences

Outils

MS Project

Smartsheet

Description du poste

Kailera is seeking a Senior Clinical Trial Manager to oversee one or more trials across all phases. Based in Waltham, MA or remote with a hub visit cadence, this role leads cross-functional teams and manages CROs to ensure trials stay on time and within budget.

The successful candidate will drive trial start-up, monitoring, data review and database lock, maintain Trial Master Files, and mentor junior staff while ensuring GCP/ICH compliance and quality.