Senior Clinical Trial Manager / Clinical Trial Manager

Verastem•Boston, MA

13h

About The Position

At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have 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.

Requirements

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.

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.