Clinical Trial Manager

Verastem Oncology; Boston (MA); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Benefits package

Job summary

Verastem Oncology is seeking a Clinical Trial Manager with global Phase 3 trial experience to lead cross-functional teams across vendors and internal groups. You will drive study planning, initiation, execution and closure while ensuring quality, compliance, and timely deliverables.

Responsibilities include managing CROs/IRT/eTMF vendors, negotiating contracts, and supporting feasibility studies. A strong background in Oncology trials and SOP/GCP familiarity is required.

Qualifications

• Global Phase 3 clinical trial management experience.
• Minimum of 3 years of clinical trial experience, including oncology.
• BA/BS degree or equivalent in a scientific or health care field is required.

Responsibilities

• Serve as primary liaison between clinical vendors (CRO, IRT, eTMF) and Verastem Oncology to ensure scope, quality and budget adherence.
• Manage assigned trials to ensure studies run on time, within budget, and per SOPs and regulatory requirements.
• Oversee all elements of the trial lifecycle from setup to closeout, including vendor performance, metrics and communications.
• Collaborate on RFPs, review proposals, and select vendors to optimize savings.
• Negotiate master service agreements, work orders, contracts, and amendments.
• Assist in developing study-feasibilities and participate in site selection.
• Contribute to writing and reviewing Protocols, ICFs, CRFs and related documents.
• Coordinate with medical monitor and cross-functional teams to produce deliverables.
• Work with Data Management to ensure data cleaning and monitoring.
• Address issues with CROs and teams, developing risk mitigations.
• Chair cross-functional study team meetings and track actions.
• Forecast budgets with finance and update monthly/quarterly actuals.
• Help create and update SOPs with QA.

Skills

Phase 3 trials mgmt

Education

Bachelor's in science/healthcare

Job description

Summary:

WeareseekingaClinicalTrialManagerwithexperienceinmanagingaglobalPhase3clinicaltrial.WorkswithseniorClinicalOperationsmemberstoleadtheclinicalprojectteammembersintheselectionofvendorsalongwithoverseeingthecompletionofdeliverablesinatimelyfashionwithinanagreeduponprojectbudget.Generalareasofresponsibilityinclude:projectplanning,initiation,implementation,andclosure;leadingandmotivatingacrossfunctionalteam;milestoneplanningandtracking;ensuringthatprojectsareprogressingaccordingtoqualitystandards,StandardOperatingProcedures(SOPs),GoodClinicalPractice(GCP)guidelines,and/orotherguidelinestofulfilllocalregulations;productionandreviewofkeyprojectprogressreports;managementofcommunicationsbetweentheprojectteamandCROsandancillaryvendors;andcontractandfinancialmanagement.

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.
• Assistindevelopingstudy-specificfeasibilitiesandparticipateinsiteselection.
• 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).
• Updateassignedtrackingspreadsheetsonanongoingbasis.
• WorkwithFinancetoforecastbudgetsandreconcilemonthly/quarterlyactualsversusactuals.
• WorkwithQualityAssurancetocreateandupdateclinicalSOPs.

Qualifications:

• GlobalPhase3clinicaltrialmanagementexperience
• 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.
• ExcellentunderstandingofICH,GCPandotherapplicableregulatoryguidelinesrequired.
• Excellent verbal and written communication skills to effectively communicate with site staff, vendors and internal cross functional team members.
• Abilitytoprioritizeandmulti-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.