Senior Clinical Trial Manager

Senior Clinical Trial Manager

At Verastem Oncology, we address urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy for women living with recurrent KRAS-mutated lowgrade serous ovarian cancer, a rare cancer with significant unmet need. We've launched this novel/novel combination therapy in the U.S. and are exploring pathways for Europe and Japan.

We continue to advance our pipeline of drugs to help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. This is an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.

We are seeking a Senior Clinical Trial Manager with experience in managing a global Phase 3 clinical trial. Works with senior Clinical Operations members to lead the clinical project team members in the selection of vendors along with overseeing the completion of deliverables in a timely fashion within an agreed upon project budget. General areas of responsibility include: project planning, initiation, implementation, and closure;

leading and motivating a cross functional team; milestone planning and tracking; ensuring that projects are progressing according to quality standards, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and/or other guidelines to fulfill local regulations; production and review of key project progress reports; management of communications between the project team and CROs and ancillary vendors; and contract and financial management.

Responsibilities:

• Function as primary liaison between clinical vendors (CRO, IRT, eTMF) and Verastem Oncology to ensure understanding of expectations and scope of work, quality and budget. 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 including vendor performance, internal metrics, quality assurance checks and communication of trial status.
• Work with Senior Clinical Operations member on RFPs for distribution to vendors, review proposals, coordinate bid defenses and internal discussions in selecting vendors to maximize savings.
• Negotiate master service agreements, work orders, contracts, and amendments for sites/vendors.
• Assist in developing study-specific feasibilities and participate in site selection.
• Contribute to the writing and/or review of clinical documents such as Protocols, Informed Consent Forms, case report forms (CRFs) design and completion guidelines, and other study-related documents.
• Liaise with medical monitor and cross functional team members as necessary and in accordance with established SOPs to produce study deliverables (e.g., clinical protocols, CRFs, informed consent templates, project management plan, data management plan, safety management plan, medical monitoring plan, clinical monitoring plan, pharmacy/lab manuals, clinical study reports etc.).
• Work closely with Data Management to ensure ongoing data cleaning including review of data management metric, review of patient profiles and data listings.
• Work with CRO and/or core team members to address issues and risks associated with achieving the study deliverables and develop risk mitigation plan.
• Oversee monitoring activities at clinical CROs by reviewing monitoring visit reports, protocol deviations and CAPAs; attend co-monitoring visits as required.
• Chair cross functional study team meetings and maintain meeting minutes and action items for team follow-up.
• Regularly meet with Manager to discuss overall clinical trial(s) plans, update forecasting, and identify potential issues with recommended solutions.
• Identify issues and implement solutions to ensure the project remains on track; recognize the need to seek assistance or inform senior management of specific issues.
• Assume…