Clinical Trial Manager

• Function as primary liaison between clinical vendors (CRO, IRT, eTMF) and Verastem Oncology
• Proactively recognize any changes in SOW and work with CRO to manage accruals and SOW changes
• Manage assigned clinical trials to ensure that studies are conducted efficiently, on time, within budget and in accordance with established SOPs and applicable regulatory requirements
• Provide oversight of all elements of the project lifecycle from initial set-up to close out
• Work with Senior Clinical Operations member on RFPs for distribution to vendors
• Negotiate master service agreements, work orders, contracts, and amendments for sites/vendors
• Assist in developing study-specific feasibilities and participate in site selection
• Liaise with medical monitor and cross functional team members
• Work closely with Data Management to ensure ongoing data cleaning
• Oversee monitoring activities at clinical CROs by reviewing monitoring visit reports

• Global Phase 3 clinical trial management experience
• Minimum of 3 years of clinical trial experience, including prior experience in oncology clinical studies
• BA/BS degree or equivalent in a scientific or health care field is required
• Excellent understanding of ICH, GCP and other applicable regulatory guidelines required
• Excellent verbal and written communication skills to effectively communicate with site staff, vendors and internal cross functional team members
• Ability to prioritize and multi-task
• Travel may be required

Demonstrates expertise in managing global Phase 3 clinical trials, ensuring compliance with ICH and GCP guidelines, and effectively liaising with clinical vendors and cross-functional teams. Proficient in contract negotiation and oversight of project life cycles from initiation to closeout.

• Global Phase 3 Clinical Trial Management
• Oncology Clinical Studies Experience
• ICH and GCP Regulatory Knowledge
• Contract Negotiation
• Project Lifecycle Oversight

• Clinical Trial Management
• Regulatory Compliance
• Data Management
• SOP Adherence
• Feasibility Development

• Verbal Communication
• Written Communication
• Prioritization
• Multi-tasking

• Clinical Trials
• Oncology
• SOW Management
• Vendor Liaison
• Monitoring Activities

• CRO
• IRT
• ETMF