Clinical Trial Manager

SIRE® Life Sciences ?; Utrecht; On-site; EUR 85,000 - 110,000; Full time

Job summary

Genmab is seeking a Clinical Trial Manager to lead operational delivery of assigned trials, coordinating cross-functional teams and CROs to ensure on-time, on-budget studies with compliant data.

The role emphasizes risk management, budget oversight, and adherence to ICH-GCP and Genmab SOPs, with collaboration across internal and external stakeholders to drive trial success.

Qualifications

• Bachelor's or Master's degree in a relevant scientific, life sciences, or related discipline; a Master's degree is preferred.
• At least 5 years of professional experience in Clinical Operations.
• Demonstrated experience leading and managing clinical trials independently.
• Strong experience coordinating clinical study activities across multiple functions and stakeholders.
• Practical experience managing CROs or other external clinical-service providers.
• Experience maintaining and overseeing essential clinical trial documentation.
• Proven exposure to clinical trial budget monitoring and financial management.
• Strong understanding of clinical trial quality, compliance, risk management, and ICH-GCP requirements.

Responsibilities

• Lead the cross-functional Clinical Management Team for assigned trials, including oversight and coordination of CRO partners.
• Drive the operational execution of clinical studies against agreed timelines, budgets, quality expectations, and study objectives.
• Coordinate internal and external stakeholders to maintain alignment, resolve operational challenges, and ensure continued trial progress.
• Support CRO selection, define scopes of work, and oversee CRO performance throughout study delivery.
• Identify study issues and ensure appropriate and timely escalation when trial progress, quality, patient safety, or data integrity may be affected.
• Lead proactive trial risk identification, assessment, mitigation, and follow-up, with particular attention to patient safety and data integrity.
• Maintain oversight of study finances, including budget updates, forecasting, accruals, invoice review, and ongoing cost monitoring.
• Participate in audits and regulatory inspections and coordinate timely responses and follow-up activities when required.
• Ensure clinical trial activities and documentation meet relevant regulatory requirements, internal SOPs, and ICH-GCP standards.

Skills

Clinical Operations

CRO coordination

Budget management

ICH-GCP

Regulatory compliance

Cross-functional leadership

Vendor management

Data integrity

Education

Bachelor's degree in life sciences

Master's degree preferred

Job description

The Clinical Trial Manager is responsible for the operational leadership and successful delivery of assigned clinical trials. The role coordinates cross-functional study teams and external partners, including CROs, to ensure trials are executed on time, within budget, and to the required quality standards. The position works closely with internal and external stakeholders and ensures trial activities comply with applicable regulations, Genmab SOPs, and ICH-GCP requirements.

Responsibilities

• Lead the cross-functional Clinical Management Team for assigned trials, including oversight and coordination of CRO partners.
• Drive the operational execution of clinical studies against agreed timelines, budgets, quality expectations, and study objectives.
• Coordinate internal and external stakeholders to maintain alignment, resolve operational challenges, and ensure continued trial progress.
• Support CRO selection, define scopes of work, and oversee CRO performance throughout study delivery.
• Identify study issues and ensure appropriate and timely escalation when trial progress, quality, patient safety, or data integrity may be affected.
• Lead proactive trial risk identification, assessment, mitigation, and follow-up, with particular attention to patient safety and data integrity.
• Maintain oversight of study finances, including budget updates, forecasting, accruals, invoice review, and ongoing cost monitoring.
• Participate in audits and regulatory inspections and coordinate timely responses and follow-up activities when required.
• Ensure clinical trial activities and documentation meet relevant regulatory requirements, internal SOPs, and ICH-GCP standards.

Requirements

• Bachelor's or Master's degree in a relevant scientific, life sciences, or related discipline; a Master's degree is preferred.
• At least 5 years of professional experience in Clinical Operations.
• Demonstrated experience independently leading and managing clinical trials.
• Strong experience coordinating clinical study activities across multiple functions and stakeholders.
• Practical experience managing and overseeing CROs or other external clinical-service providers.
• Experience maintaining and overseeing essential clinical trial documentation.
• Proven exposure to clinical trial budget monitoring and financial management.
• Strong understanding of clinical trial quality, compliance, risk management, and ICH-GCP requirements.