Verastem

Verastem

Clinical Trial Associate

Boston, Massachusetts

Sponsorship not specified$86k-$100kDetected 7 days ago
GCPProject ManagementExcelClinical TrialsClinical ResearchFDA RegulatoryResearchPublic SpeakingMicrosoft OfficeGxP

About the role

  • FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy for women living with recurrent KRAS-mutated low-grade 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.

Responsibilities

  • Manages trial related documents in the Veeva Vault Trial Master File (TMF)
  • manages user access and facilitate training for internal/external users as needed
  • Uploads and reviews TMF documents for completeness, accuracy and compliance with protocol and applicable regulations, standard operating procedures and best practices.
  • Creates and maintains internal folders on company share drive(s).
  • Manages study investigator CDAs, contract approval and purchase order creation.
  • Assists in the creation of study materials, including but not limited to documents, presentations and reports.
  • Supports CPM to established and maintain the tracking tools for project metrics such as site activation, patient enrollment and site contacts.
  • Reviews and assists in the collection of essential documents for completeness and compliance with SOPs, the protocol and appropriate regulations.
  • Creates and reviews IMP release packet prior to initiation
  • Manages trial related documents in the Veeva Vault Trial Master File (TMF); manages user access and facilitate training for internal/external users as needed; trains new users.

Requirements

  • Bachelor's degree or nursing degree is required.
  • Minimum of 4 years' experience in relevant field (e.g. clinical site, CRO, Sponsor or clinical trial vendor).
  • Relevant experience in clinical research or related field.
  • General knowledge of guidelines governing clinical research.
  • Comfortable with technology and ability to learn new systems quickly.
  • Strong knowledge of MS Word, Excel, PowerPoint and Outlook.
  • Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization.
  • Must be able to work in a fast-paced environment with demonstrated ability to work on multiple competing tasks and demands.
  • Ability to work successfully within a cross-functional team.
  • Performs quality checks and follow-up on resolution of open issues to ensure cross functional study team members are compliant with use of required documents within the TMF.
  • Bachelor's degree or nursing degree is required. Scientific/health care field preferred, but not required.
  • Adequate Good Clinical Practice training.
  • Experienced with Veeva TMF.
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
  • T he base salary range (86K-100K) 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.

Compensation

  • T he base salary range (86K-100K) provided reflects our current estimate of what we anticipate paying for this position.

Visa & Work Authorization

  • clinical site, CRO, Sponsor or clinical trial vendor)
Apply directly at Verastem →Create a free account for alerts like thisView Verastem immigration profile

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