Verastem

Senior Clinical Trial Manager

Boston, Massachusetts · Senior

Sponsorship not specified$115k-$130kDetected 6 days ago

GCPProject ManagementForecastingClinical TrialsFDA RegulatoryCommunicationGxP

About the role

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.

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.
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.
Work with CRO and/or core team members to address issues and risks associated with achieving the study deliverables and develop risk mitigation plan.
Chair cross functional study team meetings and maintain meeting minutes and action items for team follow-up.
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.
Work with Quality Assurance to create and update clinical SOPs.

Minimum of 5-7 years of clinical trial experience, including prior experience in oncology clinical studies.
Excellent understanding of ICH, GCP and other applicable regulatory guidelines required.
Ability to prioritize and multi- task.
Travel may be required.
attend co-monitoring visits as required.
Global Phase 3 clinical trial management experience
Minimum of 5-7 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 verbal and written communication skills to effectively communicate with site staff, vendors and internal cross functional team members.
The base salary range (115K-130K) provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

The base salary range (115K-130K) provided reflects our current estimate of what we anticipate paying for this position.

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.

This listing is sourced directly from Verastem's careers page and normalized into a canonical job model.