Senior Clinical Trial Manager

Verastem Oncology; Boston (MA); On-site; USD 130,000 - 160,000; Full time

Job summary

Verastem Oncology seeks a Senior Clinical Trial Manager to lead a global Phase 3 trial, coordinating cross-functional teams and vendors to ensure timely, quality deliverables within budget. You will manage the full lifecycle from planning to closure, ensuring SOPs, GCP and regulatory adherence, with frequent interaction with CROs and internal stakeholders.

The role requires 5–7 years of clinical trial experience (oncology preferred) and a BA/BS in a scientific or healthcare field, with strong

Qualifications

• Global Phase 3 clinical trial management experience.
• Minimum of 5-7 years of clinical trial experience, including oncology studies.
• BA/BS degree or equivalent in a scientific/healthcare field.
• Excellent understanding of ICH, GCP and regulatory guidelines.
• Strong verbal and written communication skills.
• Willingness to travel.

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.
• Manage assigned clinical trials to ensure that studies are conducted efficiently, on time, within budget and in accordance with SOPs and regulatory requirements.
• Provide oversight of all elements of the project lifecycle from setup to close-out including vendor performance, internal metrics, quality assurance checks and trial status communication.
• Work with Senior Clinical Operations to review RFPs and select 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 writing/review of clinical documents such as Protocols, ICFs, CRFs and related guidelines.
• Liaise with medical monitor and cross-functional team to produce study deliverables.
• Collaborate with Data Management to ensure ongoing data cleaning and data listings.
• Address issues and risks with CROs and develop risk mitigation plans.
• Oversee monitoring activities at clinical CROs and participate in co-monitoring visits as needed.
• Chair cross-functional study team meetings and maintain minutes and action items.
• Regularly meet with Manager to discuss study plans, forecast, and identify issues with solutions.
• Identify issues and implement solutions; inform senior management when needed.
• Set up trial master file and ensure the trial is audit-ready at all times.
• Review and implement corrective action plans with QA at vendors and sites.
• Update tracking spreadsheets and coordinate with Finance on budgets.
• Work with Quality Assurance to create and update clinical SOPs.

Skills

Global Phase 3 trial management

ICH & GCP knowledge

Verbal and written communication

Prioritization & multitasking

Oncology clinical studies experience

Education

BA/BS degree or equivalent in a scientific or health care field

Job description

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.

Summary:

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 responsibility for setting up trial master file and ensuring the trial(s) is "audit ready" at all times.
• Review, complete and ensure implementation of corrective action plans in conjunction with manager and quality assurance at vendor(s), and individual site(s) as applicable. May participate in internal/external study related audit(s).
• Update assigned tracking spreadsheets on an ongoing basis.
• Work with Finance to forecast budgets and reconcile monthly/quarterly actuals versus actuals.
• Work with Quality Assurance to create and update clinical SOPs.

Qualifications:

• 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 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.

The base salary range ($130K-$160K) 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.