Associate Director, Global Clinical Trial Management

Associate Director, Global Clinical Trial Management

Genmab

Utrecht, Netherlands

The Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a single or multiple clinical trials from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical trials including managing the trial budget. The GCTM is accountable for trial deliverables and acts as point person for coordination of the TM team. The GCTM can at all times take the responsibilities of a CTM. If no CTM resource is assigned to a trial the GCTM takes on the CTM role too.

Responsibilities

• Lead the Clinical Trial Team (CTT) and Trial Management (TM) team
• Define and align CTT goals collaboratively with the team
• Review and approve protocol and amendment changes
• Review the Master Informed Consent Form (ICF)
• Approve operational plans, manuals, and charters for the trial
• Oversee the vendor selection process
• Initiate and verify the accuracy and completeness of initial Work Orders (WO) and Change Orders (CO)
• Guide the country selection process
• Coordinate responses to IEC/IRB comments
• Monitor major protocol deviations (PDs) and trends
• Approve data cleaning plans
• Collaborate with CPL as needed for CST/CDT
• Establish and maintain clear responsibility distribution
• Review and contribute to the CSR as needed
• Escalate issues to CPL in a timely manner
• Execute operational strategies related to drug supply, regulatory submissions, and recruitment

Budget and Planning

• Assist in the initial development and management of the trial budget
• Plan, implement, and maintain detailed, integrated trial timelines from the study outline through CSR
• Develop initial recruitment projections and strategy
• Approve updated recruitment projections in alignment with CPL
• Serve as the counterpart for CRO PL/PM, approving the CV of PL/PM

Risk Management

• Identify study risks with the CTT and oversee risk management activities
• Maintain and oversee the CTT issue log and ensure timely issue resolution
• Ensure CTT action and decision logs are up-to-date
• Support audit preparation and responses
• Implement Corrective and Preventive Actions (CAPAs), if applicable

Requirements

• Bachelor's or Master's degree with relevant specialization; Master's degree preferred
• Minimum requirement: 5+ years in clinical operations
• Significant experience leading clinical projects
• Experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teams
• Some experience with operational management and budget planning
• Proven performance in earlier role/comparable role

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Apply Now

More Job Searches

Netherlands      Clinical Research      On-site      Genmab