Summary: We are seeking a 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 ve…
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The Clinical Trial Manager leads cross-functional teams to oversee global Phase 3 clinical trials, ensuring adherence to budgets, timelines, and regulatory standards. They serve as the primary liaison between vendors and the company while managing study documentation, data cleaning, and audit readiness.
Requirements
Candidates must have at least 3 years of clinical trial experience, including specific experience in oncology and global Phase 3 studies. A bachelor's degree in a scientific or healthcare field and a strong understanding of ICH and GCP guidelines are required.
Full job description
Summary:
We are seeking a 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 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.
The base salary range ($100K - $125K) 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.
Verastem Oncology (Nasdaq: VSTM) (Verastem, Inc.) is a biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS G12D inhibition.
Pursuing unexplored pathways demands that we’re purposeful in everything we do. And it’s an endeavor that’s only possible with an experienced team of employees and partners dedicated to a singular purpose: changing and improving the way cancer is treated by delivering novel therapies that address areas of high unmet need in RAS/MAPK pathway-driven cancers. At Verastem Oncology, it takes our diversity of backgrounds, expertise, perspectives, and skills to find the answers that patients need, but don’t have—yet. To join our team or for more information, please visit www.verastem.com.
X/Twitter: @VerastemOncolog
Offices: 117 Kendrick Street, Suite 500, Needham, Massachusetts 02494, US
Oncologypharmaceuticalbiotechnologycancerclinical trialsand cancer researchBiopharmaBiotechnologyPharmaceutical
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